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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01588990
Registration number
NCT01588990
Ethics application status
Date submitted
27/04/2012
Date registered
1/05/2012
Date last updated
22/01/2019
Titles & IDs
Public title
A Translational Study of Bevacizumab in Participants With Metastatic Colorectal Cancer
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Scientific title
An Australian Translational Study to Evaluate the Prognostic Role of Inflammatory Markers in Patients With Metastatic Colorectal Cancer Treated With Bevacizumab (Avastin™)
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Secondary ID [1]
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ML25753
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Universal Trial Number (UTN)
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Trial acronym
ASCENT
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Capecitabine
Treatment: Drugs - Bevacizumab
Treatment: Drugs - Leucovorin
Treatment: Drugs - 5-Fluouracil
Treatment: Drugs - Irinotecan
Experimental: Bevacizumab: Phase A and Phase B - The trial will consist of 2 phases of treatment. Phase A: Participants will receive bevacizumab 7.5 mg/kg intravenous (IV) infusion on Day 1 every 3 weeks in combination with XELOX (capecitabine and oxaliplatin) or bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with mFOLFOX6 (oxaliplatin, leucovorin, and 5-fluouracil) until first disease progression or occurrence of unmanageable toxicity. Phase B: Upon documented first disease progression, participants will continue receiving bevacizumab 5 mg/kg IV on Day 1 every 2 weeks in combination with FOLFIRI (irinotecan, leucovorin, and 5-fluouracil) until second disease progression or occurrence of unmanageable toxicity. Phase B treatment should commence within 4 weeks of the date of documented first disease progression.
Treatment: Drugs: Oxaliplatin
Participants will receive oxaliplatin 85 milligrams per square meter (mg/m^2) IV infusion on Day 1 of every 2 weeks cycle during alternative Phase A treatment or 130 mg/m^2 on Day 1 of every 3 weeks cycle during Phase A treatment.
Treatment: Drugs: Capecitabine
Participants will receive capecitabine 1000 mg/m^2 per oral (PO) twice daily on Days 1-14 of 3 weeks cycle during Phase A treatment.
Treatment: Drugs: Bevacizumab
Participants will receive 7.5 mg/kg IV infusion on Day 1 every 3 weeks (Phase A treatment) or 5 mg/kg IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B).
Treatment: Drugs: Leucovorin
Participants will receive leucovorin 400 mg/m^2 IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B). Investigators may elect to chose low dose of leucovorin (either 20 mg/m^2 or 50 mg total dose).
Treatment: Drugs: 5-Fluouracil
Participants will receive 5-fluouracil loading dose of 400 mg/m^2 IV on Day 1 followed by 2400 mg/m^2 continuous IV infusion over 46 hours Day 1 (Alternative Phase A treatment and Phase B).
Treatment: Drugs: Irinotecan
Participants will receive irinotecan 180 mg/m^2 IV on Day 1 every 2 weeks during Phase B treatment.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Association Between Neutrophil to Lymphocyte Ratio (NLR) [NLR =5 Versus NLR >5] and Progression-Free Survival (PFS) as Assessed by Hazard Ratio
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Assessment method [1]
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NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. PFS was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (carcinoembryonic antigen [CEA]) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between NLR (NLR less than or equal to [=] 5 vs greater than [>] 5) and PFS was reported as hazard ratio.
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Timepoint [1]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [1]
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PFS Until First Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase A
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Assessment method [1]
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PFS until first progression was defined as the time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS.
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Timepoint [1]
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Baseline up to first disease progression, death or end of study (up to 4 years)
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Secondary outcome [2]
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PFS Until Second Disease Progression as Assessed by the Investigator Based on Routine Clinical Practice: Phase B
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Assessment method [2]
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PFS in Phase B (PFS-B) was defined as the time from the start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate PFS.
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Timepoint [2]
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From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
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Secondary outcome [3]
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Time to Failure of Strategy (TFS): Overall
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Assessment method [3]
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TFS was defined as time from the start of initial treatment to documentation of first disease progression without entering Phase B, or second disease progression having entered Phase B. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate TFS.
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Timepoint [3]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [4]
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Duration of Disease Control (DDC) as Assessed by the Investigator Based on Routine Clinical Practice: Overall
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Assessment method [4]
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DDC was defined as PFS + PFS-B. In cases where a participant did not enter Phase B, then DDC was defined as PFS. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. PFS-B was time from start of Phase B treatment to documentation of second disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate DDC.
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Timepoint [4]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [5]
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Overall Survival (OS) From the Start of Treatment to Study Completion: Overall
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Assessment method [5]
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OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. Kaplan-Meier methodology was used to estimate OS.
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Timepoint [5]
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Baseline until death or end of study (up to 4 years)
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Secondary outcome [6]
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Survival Beyond First Disease Progression: Overall
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Assessment method [6]
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Survival beyond first progression was defined as the time from the date of first disease progression to death due to any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as any of the following: an unequivocal and clinically meaningful increase in the size of known tumors, the appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. Kaplan-Meier methodology was used to estimate survival beyond first disease progression.
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Timepoint [6]
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Baseline until death or end of study (up to 4 years)
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Secondary outcome [7]
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OS: Phase B
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Assessment method [7]
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Overall Survival in Phase B was defined as the time from the start of treatment in Phase B to death due to any cause. Kaplan-Meier methodology was used to estimate OS.
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Timepoint [7]
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From the start of Phase B treatment death or end of study (up to 4 years)
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Secondary outcome [8]
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase A
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Assessment method [8]
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Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment.
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Timepoint [8]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [9]
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Phase B
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Assessment method [9]
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Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment.
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Timepoint [9]
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From the start of Phase B treatment to disease progression, death or end of study (up to 4 years)
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Secondary outcome [10]
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Percentage of Participants With Confirmed Complete or Partial Response as Assessed by the Investigator Based on Routine Clinical Practice: Overall
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Assessment method [10]
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Percentage of participants with best overall response of confirmed complete response or partial response based on the investigator assessment of the response as per routine clinical practice was reported. The confirmation of response must be no less than 4 weeks after initial assessment.
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Timepoint [10]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [11]
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Percentage of Participants Who Underwent Liver Resection: Overall
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Assessment method [11]
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The results include percentage of participants who underwent potentially curative liver resection.
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Timepoint [11]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [12]
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Association Between NLR (NLR =5 Versus NLR >5) and OS as Assessed by Hazard Ratio
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Assessment method [12]
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NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between NLR (NLR = 5 vs > 5) and OS was reported as hazard ratio.
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Timepoint [12]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [13]
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Association Between NLR Normalization (First NLR Post-Baseline =5 Versus NLR >5) and PFS as Assessed by Hazard Ratio
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Assessment method [13]
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NLR was calculated from laboratory values as ratio of Neutrophils to Lymphocytes. NLR normalization was assessed by adding first post-baseline measurement of NLR to the primary model. This is equivalent to testing whether first change in NLR is significantly associated with outcome. PFS was defined as time from start of initial treatment to documentation of first disease progression or death from any cause. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of =1 new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration.The association between NLR normalization (first NLR post-baseline =5 vs >5) and PFS was reported as hazard ratio.
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Timepoint [13]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [14]
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Association Between Longitudinal NLR (Longitudinal NLR =5 Versus NLR >5) and PFS as Assessed by Hazard Ratio
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Assessment method [14]
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NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. PFS was defined as time from the start of initial treatment to documentation of first disease progression or death from any cause, whichever occurred first. Disease progression was determined according to standard practice based on radiological, biochemical (CEA) or clinical factors. Determination of disease progression was to be unequivocal and was defined as: an unequivocal and clinically meaningful increase in size of known tumors, appearance of one or more new lesions, death due to disease without prior objective documentation of progression, elevated CEA accompanied by other radiological or clinical evidence of progression, or symptomatic deterioration. The association between longitudinal NLR (longitudinal NLR =5 vs N>5) and PFS was reported as hazard ratio.
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Timepoint [14]
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Baseline up to disease progression, death or end of study (up to 4 years)
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Secondary outcome [15]
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Association Between Longitudinal NLR (Longitudinal NLR =5 Versus NLR >5) and OS as Assessed by Hazard Ratio
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Assessment method [15]
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NLR was calculated from the laboratory values as the ratio of Neutrophils to Lymphocytes. Longitudinal NLR was assessed by treating the NLR measurements taken over the time-course of treatment as a time-dependent covariate. OS was defined as the time from the start of initial treatment to the date of death, regardless of the cause of death. The association between longitudinal NLR (longitudinal NLR =5 vs NLR >5) and OS was reported as hazard ratio.
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Timepoint [15]
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0
Baseline up to death or end of study (up to 4 years)
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Secondary outcome [16]
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European Quality of Life 5-Dimension (EuroQol-5D) Utility Score: Phase A
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Assessment method [16]
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EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is "today" and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life.
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Timepoint [16]
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Baseline, every 8-9 weeks thereafter, end of treatment (EOT) (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Secondary outcome [17]
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EuroQol-5D Utility Score: Phase B
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Assessment method [17]
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EQ-5D is a standardized generic preference based health related quality of life instrument. It records how one's health is "today" and consists of a descriptive system. The descriptive system is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension on the EQ-5D involves a 3-point response scale which indicates the level of impairment (level 1 = no problem; level 2 = some or moderate problem[s] and level 3 = unable, or extreme problems). Level of problem reported in each EQ-5D dimension determines a unique health state which is converted into a weighted health state index by applying scores from EQ-5D preference weights elicited from general population samples. This generates a unique description of the subjects' health status, which is valued between 0 (representing death) and 1 (representing perfect health). Higher the score, the better the quality of life.
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Timepoint [17]
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Secondary outcome [18]
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Assessment of Quality of Life - Eight Dimensions (AQoL-8D) Global Utility Score: Phase A
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Assessment method [18]
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AQoL-8D provides a global utility score and comprised of 35 questions from which 8 dimensions (Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses) are derived. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health).
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Timepoint [18]
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Secondary outcome [19]
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AQoL-8D Global Utility Score: Phase B
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Assessment method [19]
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AQoL-8D provides a global utility score and consists of 8 separately scored dimensions including Independent Living, Life Satisfaction, Mental Health, Coping, Relationships, Self Worth, Pain, and Senses. Each of the 8 scales is calculated based on the answers to 3 questions. Each question is given an answer dependent utility score (0 [worst] to 1 [best]) and then these scores are combined using a multiplicative model to get the normalized scale score value, each scale ranging between 0.0 (representing death) and 1.0 (representing full health).
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Timepoint [19]
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Secondary outcome [20]
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Functional Assessment of Cancer Therapy-Colorectal (FACT-C) Score: Phase A
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Assessment method [20]
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FACT-C is one part of the Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.
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Timepoint [20]
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Secondary outcome [21]
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FACT-C Score: Phase B
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Assessment method [21]
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FACT-C is one part of the FACIT Measurement System, which comprehensively assesses the health-related QoL of cancer participants and participants with other chronic illnesses. It is composed of 27 items of the general version of the FACT-C as a general core QoL measure and has a disease-specific subscale containing 9 colorectal cancer-specific items. It consists of total 36 items, summarized to 5 subscales: physical well-being (7 items), functional well-being (7 items), social/family well-being (7 items); all 3 subscales range from 0 to 28, emotional well-being (6 items) range from 0 to 24, colorectal cancer subscale (9 items) range from 0 to 36; higher subscale score=better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score range: 0 to 144. High scale score represents a better QoL.
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Timepoint [21]
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Baseline, every 8-9 weeks thereafter, EOT (30 days after disease progression [up to 4 years]), survival follow-up 12-weekly visits (up to 4 years) [Detailed time points are presented in the category titles]
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Eligibility
Key inclusion criteria
For resected primary tumor participants, and participants with primary tumor in situ:
- Previously untreated metastatic colorectal cancer and not a candidate for curative
resection
- World Health Organization (WHO) performance status of 0-1
- Life expectancy of greater than or equal to (>/=) 3 months
- Eligible for XELOX, mFOLFOX6, FOLFIRI and bevacizumab treatment in accordance with
local standards of care and pharmaceutical benefits scheme guidelines
Additional inclusion criteria for participants with primary tumor in situ:
- Intact primary tumor of the colon or the rectum not requiring surgical intervention
prior to study start
- Minimal or asymptomatic primary tumor
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Resected primary tumor participants, and participants with primary tumor in situ:
- Previous chemotherapy for metastatic colorectal cancer
- Previous neoadjuvant or adjuvant chemotherapy less than 6 months prior to study start
- Radiotherapy within 28 days prior to enrollment or not recovered from a radiotherapy
- History of non-colorectal cancer (participants are eligible if disease-free for >/=5
years and the risk of recurrence is deemed low)
- Presence of active inflammatory bowel disease
- History of gastrointestinal perforations
- Peritoneal disease
- History of significant bleeding event
- Significant vascular disease
- Peripheral arterial thrombosis or other thrombotic event within 6 months before study
start
Additional exclusion criteria for participants with primary tumor in situ:
- Prior endoscopic management of the current tumor
- Acute diverticulitis
- Presence of intra-abdominal abscess
- Active gastroduodenal ulcer
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 4
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/06/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/09/2016
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Sample size
Target
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Accrual to date
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Final
128
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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0
Canberra Hospital - Garran
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Recruitment hospital [2]
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0
Macarthur Cancer Therapy Centre - Campbelltown
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Recruitment hospital [3]
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0
Chris O'Brien Lifehouse - Camperdown
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Recruitment hospital [4]
0
0
St Vincent'S Hospital; Clinical Oncology - Darlinghurst
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Recruitment hospital [5]
0
0
Mid North Coast Cancer Institute - Port Macquarie
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Recruitment hospital [6]
0
0
Royal North Shore Hospital; Department of Medical Oncology - St Leonards
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Recruitment hospital [7]
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0
Sydney Adventist Hospital; Clinical Trial Unit - Sydney
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Recruitment hospital [8]
0
0
Royal Brisbane Hospital - Brisbane
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Recruitment hospital [9]
0
0
Rockhampton Hospital - Rockhampton
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Recruitment hospital [10]
0
0
The Townsville Hospital; Townsville Cancer Centre - Townsville
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Recruitment hospital [11]
0
0
Lyell McEwin Hospital; Oncology Clinical Trials, Chemotherapy Day Unit - Elizabeth Vale
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Recruitment hospital [12]
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0
Calvary North Adelaide; North Adeliade Oncology Centre - North Adelaide
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Recruitment hospital [13]
0
0
Launceston General Hospital - Launceston
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Recruitment hospital [14]
0
0
Austin Hospital; Medical Oncology - Heidelberg
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Recruitment hospital [15]
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0
Sunshine Hospital; Oncology Research - St Albans
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Recruitment hospital [16]
0
0
St John of God Murdoch Hospital; Oncology West - Murdoch
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Recruitment hospital [17]
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0
St John of God Hospital; Bendat Cancer Centre - Subiaco
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Recruitment postcode(s) [1]
0
0
2605 - Garran
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Recruitment postcode(s) [2]
0
0
2560 - Campbelltown
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Recruitment postcode(s) [3]
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0
2050 - Camperdown
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Recruitment postcode(s) [4]
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0
2010 - Darlinghurst
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Recruitment postcode(s) [5]
0
0
2444 - Port Macquarie
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Recruitment postcode(s) [6]
0
0
2065 - St Leonards
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Recruitment postcode(s) [7]
0
0
2076 - Sydney
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Recruitment postcode(s) [8]
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0
4029 - Brisbane
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Recruitment postcode(s) [9]
0
0
4700 - Rockhampton
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Recruitment postcode(s) [10]
0
0
4812 - Townsville
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Recruitment postcode(s) [11]
0
0
5112 - Elizabeth Vale
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Recruitment postcode(s) [12]
0
0
5006 - North Adelaide
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Recruitment postcode(s) [13]
0
0
7250 - Launceston
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Recruitment postcode(s) [14]
0
0
3084 - Heidelberg
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Recruitment postcode(s) [15]
0
0
- St Albans
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Recruitment postcode(s) [16]
0
0
6150 - Murdoch
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Recruitment postcode(s) [17]
0
0
6008 - Subiaco
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This open-label, prospective, single-arm, multicenter study will evaluate the relationship of
the markers of inflammation and progression-free survival (PFS) in participants with
previously untreated metastatic colorectal cancer. The study consists of two phases: Phase A
treatment: oral capecitabine plus infusional oxaliplatin (XELOX) plus bevacizumab, or
modified infusional 5-fluorouracil (5-FU), leucovorin (LV) and oxaliplatin (mFOLFOX6) plus
bevacizmab administered until first disease progression. Participants will then continue with
Phase B treatment: infusional 5-FU, LV and irinotecan (FOLFIRI) plus bevacizumab until second
disease progression. The anticipated time on study treatment is 4 years.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01588990
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01588990
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