Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo
18 Years
80 Years
Both
Colorectal Cancer
Trial Information
Randomized Phase III Trial Comparing in a Preoperative Schedule the Result of Two Concurrent Chemoradiation Schemes (45 Gy + Capecitabine vs 50 Gy + Capecitabine - Oxaliplatin) on the Rate of Sterilization of the Operative Specimen in Resectable Rectal Carcinomas T3-4 No-2 Mo
OBJECTIVES:
Primary
- Compare the efficacy of neoadjuvant chemoradiotherapy comprising radiotherapy and
capecitabine with vs without oxaliplatin followed by total mesorectal excision, in
terms of the rate of complete surgical resection, in patients with resectable stage II
or III rectal cancer.
Secondary
- Compare overall and disease-free survival of patients treated with these regimens.
- Compare clinical tumor response in patients treated with these regimens.
- Compare acute and late toxicity of these regimens in these patients.
- Determine biological parameters that predict tumor response and treatment-related
toxicity in patients treated with these regimens.
- Compare sphincter preservation and function in patients treated with these regimens.
OUTLINE: This is a randomized, controlled, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients undergo radiotherapy once daily 5 days a week and receive capecitabine
once daily 5 days a week in weeks 1-5.
- Arm II: Patient undergo radiotherapy and receive capecitabine as in arm I. Patients
also receive oxaliplatin once weekly in weeks 1-5.
All patients undergo total mesorectal excision 6 weeks after completion of
chemoradiotherapy.
PROJECTED ACCRUAL: A total of 590 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the rectum
- T3-4, N0-2, M0 disease by endorectal ultrasound
- T2 disease located in the low rectum allowed provided lower pole is ≤ 6 cm
from the anal verge
- Tumor must be accessible to digital rectal examination (i.e., tumor located at low-
or mid-rectum)
- Resectable disease treatable with chemoradiotherapy
- No unresectable disease (i.e., T4 disease with high risk for incomplete gross
resection [i.e., R2])
PATIENT CHARACTERISTICS:
Age
- 18 to 80
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- WBC ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Hemoglobin > 10 g/dL
Hepatic
- Alkaline phosphatase normal
- Bilirubin normal
Renal
- Creatinine ≤ 130 μmol/L
- No severe renal insufficiency
Cardiovascular
- No cardiac insufficiency
- No symptomatic coronary artery disease
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No contraindication to study treatment
- Prior acute intestinal obstruction allowed provided patient underwent surgical
diversion with stoma
- No history of other cancer except basal cell skin cancer or carcinoma in situ of the
cervix
- No peripheral neuropathy
- No uncontrolled diabetes
- No other uncontrolled severe disease
- No geographical, social, or psychological condition that would preclude study
follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for cancer
- No other concurrent chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for cancer
Surgery
- Not specified
Other
- No concurrent phenytoin
- No concurrent participation in another clinical trial of an experimental medical
treatment
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Outcome Measure:
Rate of complete surgical resection
Safety Issue:
No
Principal Investigator
Jean-Pierre Gerard, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Antoine Lacassagne
Authority:
United States: Federal Government
Study ID:
CDR0000445034
NCT ID:
NCT00227747
Start Date:
July 2005
Completion Date:
Related Keywords:
- Colorectal Cancer
- adenocarcinoma of the rectum
- stage II rectal cancer
- stage III rectal cancer
- Rectal Neoplasms
- Colorectal Neoplasms
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