Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer
|ClinicalTrials.gov Identifier: NCT00227747|
Recruitment Status : Unknown
Verified December 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : September 28, 2005
Last Update Posted : April 15, 2010
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as capecitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving radiation therapy together with combination chemotherapy before surgery may shrink the tumor so it can be removed. It is not yet known whether giving radiation therapy together with capecitabine is more effective with or without oxaliplatin before surgery in treating rectal cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy, capecitabine, and oxaliplatin to see how well they work compared to radiation therapy and capecitabine in treating patients who are undergoing surgery for stage II or stage III rectal cancer.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: capecitabine Drug: oxaliplatin Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: radiation therapy||Phase 3|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||590 participants|
|Official Title:||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|
|Study Start Date :||July 2005|
- Rate of complete surgical resection
- Overall survival
- Disease-free survival
- Sphincter preservation
- Sphincter function
- Biological parameters that predict tumor response and treatment-related toxicity
- Acute and late toxicity
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00227747
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|Study Chair:||Jean-Pierre Gerard, MD||Centre Antoine Lacassagne|