Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000403336
Ethics application status
Approved
Date submitted
28/04/2008
Date registered
18/08/2008
Date last updated
3/06/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone in locally advanced rectal cancer
Scientific title
Preoperative chemoradiotherapy and postoperative chemotherapy with capecitabine and oxaliplatin vs. capecitabine alone to establish disease-free survival outcomes in locally advanced rectal cancer (PETACC-6)
Secondary ID [1] 252835 0
Nil
Secondary ID [2] 253212 0
NCT00766155
Universal Trial Number (UTN)
Trial acronym
PETACC-6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal cancer 3093 0
Locally Advanced Rectal Cancer 252284 0
Condition category
Condition code
Cancer 3251 3251 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 252465 252465 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Radiotherapy: 0.8 Gy per fraction given every week day for 5 weeks, total of 45 Gy in 25 fractions.
Capecitabine: (oral tablets) 1650mg/m2 daily on day 1-33 pre-operatively and 2000mg/m2 daily from day 1 to day 15 for 6 21-day cycles post-operatively
AND Oxaliplatin: (intravenously) 50mg/m2 on days 1, 8, 15, 22, and 29 pre-operatively and 130mg/m2 on day 1 for 6 21-day cycles post-operatively.
Intervention code [1] 2834 0
Treatment: Drugs
Intervention code [2] 241602 0
Treatment: Drugs
Comparator / control treatment
Radiotherapy: 0.8 Gy per fraction given every week day for 5 weeks, total of 45 Gy in 25 fractions.
Capecitabine: (oral tablets) 1650mg/m2 daily on day 1-33 pre-operatively and 2000mg/m2 daily from day 1 to day 15 for 6 21-day cycles post-operatively.
Control group
Active

Outcomes
Primary outcome [1] 4135 0
Disease-free survival, defined as the time interval from randomisation to the first event of loco-regional failure, metastatic recurrence, the appearance of a secondary colorectal cancer or death.
Timepoint [1] 4135 0
During Treatment: 4-8 weeks after surgery and at the end of last cycle of chemotherapy; or as indicated if suspected progression. Follow-up: every 3 months for 3 years, then every 6 months for years 4-5, or as required if suspected progression.
Secondary outcome [1] 6966 0
Overall survival
Timepoint [1] 6966 0
Every 3 months for 3 years then every 6 months thereafter. Patient followed-up for survival for a minimum of 5 years, however follow-up until death is desirable.
Secondary outcome [2] 6967 0
Loco-regional failure. Measured via Computed tomography (CT) scan.
Timepoint [2] 6967 0
During Treatment: 4-8 weeks after surgery and at the end of last cycle of chemotherapy; or as indicated if suspected progression.
Follow-up: every 3 months for 3 years, then every 6 months for years 4-5, or as required if suspected progression.
Secondary outcome [3] 6968 0
Distant failure. Measured via CT scan.
Timepoint [3] 6968 0
During Treatment: 4-8 weeks after surgery and at the end of last cycle of chemotherapy; or as indicated if suspected progression.
Follow-up: every 3 months for 3 years, then every 6 months for years 4-5, or as required if suspected progression.
Secondary outcome [4] 6969 0
Pathological downstaging rate, complete remission rate and tumor regression grade. Measured via CT scan.
Timepoint [4] 6969 0
Following pre-operative treatment, within 1 week prior to surgery.
Secondary outcome [5] 6970 0
Histopathological R0 resection rate
Timepoint [5] 6970 0
At surgery
Secondary outcome [6] 6971 0
Sphincter preservation rate. Assessed through surgery reports and physical examination.
Timepoint [6] 6971 0
At baseline and surgery
Secondary outcome [7] 6972 0
Perioperative complication rate (e.g. infection, surgery-associated bleeding, renal failure, deep venous thromboembolism, etc.). Assessed through surgery reports and physical examination.
Timepoint [7] 6972 0
Within 30 days post surgery
Secondary outcome [8] 6973 0
Toxicity. Assessed through physical examination and patient reports.
Timepoint [8] 6973 0
Weekly during chemoradiation treatment, within 1 week before surgery, 4-8 weeks post-surgery, before each cycle during post-operative chemotherapy and at the end of the last cycle of chemotherapy. During follow-up, every 3 months for the first 3 years, then every 6 months for years 4-5.

Eligibility
Key inclusion criteria
1.Male or female patients with histologically proven adenocarcinoma of the rectum (tumour = 12 cm from the anal verge as assessed by rigid proctoscopy)
2.T3/4 or any node-positive disease
3.No evidence of metastatic disease
4.The disease must be considered either resectable at the time of entry or expected to become resectable after preoperative chemoradiation.
5.Age = 18 years.
6.World Health Organisation (WHO) / Eastern Cooperative Oncology Group (ECOG) Performance Status = 2
7.No prior cytotoxic chemotherapy or radiotherapy for rectal cancer.
8.No prior radiotherapy of the pelvis, for any reason.
9.Presence of adequate contraception in fertile patients. Pregnant or breastfeeding women are excluded from participation.
10.Adequate bone marrow, hepatic and renal function:
11.Haemoglobin = 10.0 g/dL, absolute neutrophil count = 1.5 x 109/L, platelet count = 100 x 109/L,
12. Alanine transaminase (ALAT)and aspartate transaminase (ASAT) = 2.5 x ULN
13.Alkaline phosphatase = 2.5 x ULN
14.Total bilirubin = 1.5 x ULN
15.Creatinine clearance > 50 mL/min
16.Creatinine = 1.5 x ULN
17.Ability to swallow tablets
18.Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant or breastfeeding women or fertile patients not using adequate contraception.
2.Prior cytotoxic chemotherapy or radiotherapy for rectal cancer.
3.Prior radiotherapy of the pelvis, for any reason.
4. Previous (within the last 5 years) or concurrent malignancies.
5.Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmia not well controlled with medication) or myocardial infarction within the last 12 months.
6.Significant impairment of intestinal resorption (e.g. chronic diarrhoea, inflammatory bowel disease).
7.Pre-existing condition which would deter chemoradiotherapy or radiotherapy, i.e. fistulas, severe ulcerative colitis (particularly patients currently taking Sulphasalazine), Crohn’s disease, prior adhesions.
8.Peripheral neuropathy = grade 2 (according to Common Terminology Criteria for Adverse Events (CTCAE) v3.0).
9.History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients will be centrally randomised via online randomisation system.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A minimization technique will be used for random treatment allocation stratifying by treating center, clinical T category (T1-3 vs. T4), clinical nodal status (Nx vs. N0 vs.N1-2), distance from the tumor to the anal verge (<=5 cm vs. >5 cm), availability of Magnetic Resonance Imaging (MRI) at the center (yes vs. no).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2008
Actual
27/05/2009
Date of last participant enrolment
Anticipated
Actual
9/09/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
1090
Accrual to date
Final
1090
Recruitment in Australia
Recruitment state(s)
TAS,NSW,VIC,QLD,SA,WA
Recruitment outside Australia
Country [1] 955 0
New Zealand
State/province [1] 955 0
Country [2] 956 0
Belgium
State/province [2] 956 0
Country [3] 957 0
France
State/province [3] 957 0
Country [4] 958 0
Germany
State/province [4] 958 0
Country [5] 959 0
Israel
State/province [5] 959 0

Funding & Sponsors
Funding source category [1] 3342 0
Government body
Name [1] 3342 0
Cancer Australia
Country [1] 3342 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australasian Gastro-Intestinal Trials Group (AGITG)
Address
AGITG Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 2987 0
Other Collaborative groups
Name [1] 2987 0
European Organisation for Research and Treatment of Cancer (EORTC)
Address [1] 2987 0
Avenue Mounierlaan, 83/11
Brussel 1200 Bruxelles
Country [1] 2987 0
Belgium

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5366 0
Cancer Institute NSW Clinical Research Ethics Committee
Ethics committee address [1] 5366 0
Ethics committee country [1] 5366 0
Australia
Date submitted for ethics approval [1] 5366 0
20/12/2007
Approval date [1] 5366 0
01/07/2008
Ethics approval number [1] 5366 0
2008C/01/039
Ethics committee name [2] 295182 0
SLHD Ethics Review Committee RPAH Zone
Ethics committee address [2] 295182 0
Ethics committee country [2] 295182 0
Australia
Date submitted for ethics approval [2] 295182 0
Approval date [2] 295182 0
Ethics approval number [2] 295182 0
X13-0183

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28555 0
Prof Tim Price
Address 28555 0
AGITG Coordinating Centre NHMRC Clinical Trials Centre Locked Bag 77 Camperdown NSW 1450
Country 28555 0
Australia
Phone 28555 0
+61295625000
Fax 28555 0
Email 28555 0
[email protected]
Contact person for public queries
Name 11712 0
PETACC-6 Trial Coordinator
Address 11712 0
AGITG Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 11712 0
Australia
Phone 11712 0
(02) 9562 5000
Fax 11712 0
(02) 9562 5094
Email 11712 0
[email protected]
Contact person for scientific queries
Name 2640 0
PETACC-6 Trial Coordinator
Address 2640 0
AGITG Coordinating Centre
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 2640 0
Australia
Phone 2640 0
(02) 9562 5000
Fax 2640 0
(02) 9562 5094
Email 2640 0
[email protected]

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
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