A Clinical Trial Comparing Preoperative Radiation Therapy And Capecitabine With or Without Oxaliplatin With Preoperative Radiation Therapy And Continuous Intravenous Infusion Of 5-Fluorouracil With or Without Oxaliplatin In The Treatment Of Patients With Operable Carcinoma Of The Rectum
OBJECTIVES:
Primary
- Compare the rate of local-regional relapse in patients with resectable rectal cancer
treated with chemoradiotherapy comprising radiation therapy and either capecitabine or
fluorouracil with or without oxaliplatin.
Secondary
- Compare the rate of clinical complete response in patients treated with these regimens.
- Compare the rate of pathologic complete response in patients treated with these
regimens.
- Determine the increase in the number of patients who are able to undergo
sphincter-saving surgery after treatment with these regimens.
- Correlate genetic patterns and the presence or absence of specific tissue biomarkers
with response and prognosis in patients treated with these regimens.
- Compare preoperative quality of life (QOL) of patients treated with oral capecitabine
versus continuous infusion with fluorouracil.
- Determine the impact of oxaliplatin on neurotoxicity in patients treated with these
regimens.
- Compare the toxic effects of these regimens in these patients.
- Compare the convenience of care in patients treated with these regimens.
- Determine the impact of the type of surgical management on QOL at 1 and 5 years
postoperatively in these patients.
- Describe the long-term impact of cancer treatment on symptoms (e.g., vitality and
neurotoxicity) and QOL at 5 years after randomization (5-year follow-up visit).
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, gender, clinical tumor stage (stage II vs stage III), and surgical
intent (sphincter saving vs non-sphincter saving). Patients are randomized to 1 of 4
treatment arms.
- Arm 1: Patients receive fluorouracil IV continuously and undergo radiotherapy once
daily 5 days a week for 5-6 weeks.
- Arm 2: Patients receive fluorouracil and undergo radiotherapy as in arm 1. Patients
also receive oxaliplatin IV over 1 hour once weekly for 5 weeks.
- Arm 3: Patients receive oral capecitabine twice daily and undergo radiotherapy once
daily 5 days a week for 5-6 weeks.
- Arm 4: Patients receive capecitabine and undergo radiotherapy as in arm 3. Patients
also receive oxaliplatin as in arm 2.
Within 6-8 weeks after the completion of chemoradiotherapy, patients with responding or
stable disease undergo surgery. Patients with progressive disease are treated at the
discretion of the investigator and continue to be followed.
Quality of life is assessed at baseline, at completion of chemoradiotherapy, and at 1 and 5
years after surgery.
After completion of study treatment, patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 1,606 patients will be accrued for this study within 4 years.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Loco-regional disease control as assessed by evidence of tumor at 3 years
Time from randomization to first local recurrence up to 3 years
No
Norman Wolmark, MD
Principal Investigator
NSABP Foundation, Inc.
United States: Data and Safety Monitoring Board
NSABP R-04
NCT00058474
July 2004
August 2015
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