Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer
18 Years
N/A
Both
Colorectal Cancer
Trial Information
Short Course Oncology Therapy - A Study of Adjuvant Chemotherapy in Colorectal Cancer
OBJECTIVES:
- To assess the efficacy and compare the associated toxicity of adjuvant chemotherapy
lasting 12 weeks vs 24 weeks in patients with fully resected high-risk stage II or III
colorectal cancer.
- To conduct an economic analysis of the cost effectiveness of these regimens.
- To compare the randomization methodologies used in this study.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center's recruitment potential. Patients are randomized (within 10 weeks after surgery and
before or after receiving 12 weeks of chemotherapy) to 1 of 2 treatment arms. The treatment
regimen that a patient receives (Oxaliplatin Modified DeGramont [OxMdG] or XELOX) is
determined by the participating center.
- Arm I: Patients receive 12 courses of OxMdG (described below) or XELOX (described
below)combination chemotherapy (6 additional courses if patient already received 6
courses) for treatment lasting a total of 24 weeks.
- Arm II: Patients receive 6 courses of OxMdG or XELOX combination chemotherapy (no
additional courses if patient already received 6 courses) for treatment lasting a total
of 12 weeks.
The two adjuvant combination chemotherapy regimens are administered as follows:
- OxMdG: Patients receive oxaliplatin IV over 2 hours and fluorouracil IV continuously
over 46 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of
disease progression or unacceptable toxicity.
- XELOX: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine
twice daily on days 1-14. Treatment repeats every 21 days for 6 courses in the absence
of disease progression or unacceptable toxicity.
Patients complete quality-of-life assessments periodically using the EORTC QLQ-C30, EORTC
QLQ-CR29, EQ-5D, and GOG Ntx4 questionnaires.
After completion of study treatment, patients are followed periodically for up to 7 years.
Peer Reviewed and Funded by Medical Research Council (MRC)
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Diagnosis of colorectal cancer meeting 1 of the following criteria:
- High-risk stage IIB disease, defined as T4 disease, perforation, obstruction, <
10 nodes examined, poorly differentiated histology, extramural venous invasion,
or extramural lymphatic invasion
- Fully resected stage III disease
- Patients with rectal cancer must meet the following criteria:
- Underwent prior total mesorectal excision surgery with negative resection (R0)
margins
- No prior pre-operative or scheduled post-operative combined chemotherapy and
radiotherapy
- No evidence of residual or metastatic disease
- Deemed suitable for adjuvant chemotherapy
PATIENT CHARACTERISTICS:
- WHO performance status 0-1
- Life expectancy > 5 years with reference to noncancer-related diseases
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- AST and ALT ≤ 2.5 times upper limit of normal
- Carcinoembryonic antigen (CEA) levels normal
- Glomerular filtration rate ≥ 30 mL/min (no moderate or severe renal impairment)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must effective contraception
- More than 12 months since prior and no active clinically significant cardiovascular
disease, including any of the following:
- Cerebrovascular accident
- Myocardial infarction
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- Uncontrolled hypertension (i.e., blood pressure > 150/100 mm Hg)
- Disease-free interval of ≥ 5 years for previous malignancy other than adequately
treated in situ carcinoma of the uterine cervix or basal cell or squamous cell
carcinoma of the skin
- No known or suspected dihydropyrimidine dehydrogenase deficiency
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No more than 10 weeks since prior surgery and recovered
- No prior chemotherapy (except in patients randomized after 12 weeks of adjuvant
therapy)
- No prior abdomino-pelvic radiotherapy, with the exception of short-course
pre-operative radiotherapy for rectal cancer
- No concurrent brivudine or sorivudine for patients taking capecitabine
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
3-year disease-free survival
Outcome Time Frame:
3 years
Safety Issue:
No
Principal Investigator
Tim Iveson, FRCP, MD, MRCP, MBBS, BSC
Investigator Role:
Principal Investigator
Investigator Affiliation:
University Hospital Southampton NHS Foundation Trust.
Authority:
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study ID:
CDR0000613042
NCT ID:
NCT00749450
Start Date:
March 2008
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage II colon cancer
- stage III colon cancer
- stage II rectal cancer
- stage III rectal cancer
- Colorectal Neoplasms
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