Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227747
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2005-09-26
Brief Title:
Radiation Therapy and Capecitabine With or Without Oxaliplatin in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Rectal Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FRE-FNCLCC-ACCORD-120405 | None | None | None |
| EU-20522 | None | None | None |