NCT00058474

Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,608 (actual)
• Sponsor: NSABP Foundation Inc · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, fluorouracil, and oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: This randomized phase III trial is studying radiation therapy and either capecitabine or fluorouracil with or without oxaliplatin and comparing them to see how well they work when given before surgery in treating patients with resectable rectal cancer. It is not yet known whether radiation therapy and either capecitabine or fluorouracil is more effective with or without oxaliplatin in treating rectal cancer.

Detailed description

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	capecitabine	825 mg/m2 oral daily 5 days a week on days of planned RT
DRUG	fluorouracil	225 mg/m2 IV daily continuous infusion
DRUG	oxaliplatin	50 mg/m2 IV 5 days a week on days of planned RT
RADIATION	radiation therapy	Given 5 days a week for 5-6 weeks

Timeline

• Start date: 2004-07-01
• Primary completion: 2013-08-01
• Completion: 2016-05-01
• First posted: 2003-04-09
• Last updated: 2016-03-23