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Trial registered on ANZCTR
Registration number
ACTRN12605000706673
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
2/11/2005
Date last updated
28/02/2012
Type of registration
Retrospectively registered
Titles & IDs
Public title
Phase II CPT-11, LV and 5FU in Gastric Cancer
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Scientific title
A PHASE II STUDY OF IRINOTECAN, LEUCOVORIN AND FLUOROURACIL IN ADVANCED GASTRIC CANCER TO IMPROVE DISEASE FREE SURVIVAL
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Secondary ID [1]
214
0
Australasian Gastro-Intestinal Trials Group: AG9801
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Secondary ID [2]
215
0
National Clinical Trials Registry: NCTR338
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer
856
0
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Condition category
Condition code
Cancer
922
922
0
0
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Stomach
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Chemotherapy: CPT-11, Leucovorin, 5FU. All drugs will be given in repeated six-week courses comprising weekly therapy for four weeks followed by a two-week rest period.
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Intervention code [1]
566
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None
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Comparator / control treatment
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
1207
0
Objective Response Rate
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Assessment method [1]
1207
0
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Timepoint [1]
1207
0
Every 3 months
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Secondary outcome [1]
2205
0
Toxicity
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Assessment method [1]
2205
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Timepoint [1]
2205
0
Post every cycle of chemotherapy.
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Eligibility
Key inclusion criteria
Patients must have clinically documented locally advanced or metastatic adenocarcinoma of the stomach and histologic confirmation of the diagnosis. Patients must have measurable disease (lesions > 1x1 cm by clinical measurement or chest x-ray, and > 2x2 cm by CT or ultrasound). Patients must have a performance status of 0-2 on the ECOG Performance Scale. Patients must have a predicted life expectancy of at least 12 weeks. Patients must have a pre-treatment granulocyte count (ie., segmented neutrophils + bands) of > 1.5 x 109/L, a haemoglobin level of 90 gm/L and a platelet count of > 100 x 109/L. Patients must have adequate renal function as documented by a serum creatinine 200 mol/L. Patients must have adequate hepatic function as documented by a serum bilirubin 25 mol/L, regardless of whether patients have liver involvement secondary to tumour. Aspartate transaminase (AST, SGOT) must be 3x institutional upper limit of normal unless the liver is involved with tumour, in which case the aspartate transaminase must be 5x institutional upper limit of normal. Patients must be and geographically assessable and physically capable of completing study investigations as required. Patients must give written informed consent.
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Minimum age
18
Years
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Maximum age
Not stated
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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
Patients who have previously received CPT-11 or topotecan. Patients who have received chemotherapy in both the neoadjuvant / adjuvant setting and for recurrent/metastatic disease. (Prior chemotherapy is permitted under certain conditions see section 8.1). Patients with any active or uncontrolled infection, including known HIV infection. Patients with psychiatric disorders that would interfere with consent or follow up. Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy. Patients with a history of prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for at least five years. Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Presence of clinically apparent central nervous system metastases or carcinomatous meningitis. Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other antiepileptic prophylaxis are ineligible. Patients with uncontrolled diabetes mellitus, defined as random blood sugar > 15 mmol/L. Patients with baseline serum calcium 2.70 mmol/L. Patients with known Gilbert's Disease, as these patients may have excessive CPT-11-induced toxicity. Patients with any other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into this study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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 2
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/06/1998
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Actual
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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
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Sample size
Target
80
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
1017
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Commercial sector/Industry
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Name [1]
1017
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Pharmacia
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Address [1]
1017
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Country [1]
1017
0
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Primary sponsor type
Other Collaborative groups
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Name
Site - Investigator Initiated . AGITG sponsored trial, conducted through NHMRC CTC
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Address
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Country
Australia
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Secondary sponsor category [1]
880
0
Other Collaborative groups
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Name [1]
880
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AGITG
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Address [1]
880
0
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Country [1]
880
0
Australia
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Secondary sponsor category [2]
881
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University
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Name [2]
881
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NHMRC Clinical Trials Centre
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Address [2]
881
0
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Country [2]
881
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Australia
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
35611
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Address
35611
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Country
35611
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Phone
35611
0
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Fax
35611
0
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Email
35611
0
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Contact person for public queries
Name
9755
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Burcu Cakir
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Address
9755
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National Health and Medical Research Council (NHMRC) Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
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Country
9755
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Australia
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Phone
9755
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+61 2 95625334
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Fax
9755
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+61 2 95625094
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Email
9755
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[email protected]
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Contact person for scientific queries
Name
683
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Stephen Ackland
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Address
683
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Locked Bag 77
Camperdown NSW 1450
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Country
683
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Australia
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Phone
683
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+61 2 95625334
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Fax
683
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+61 2 95625094
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Email
683
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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