Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086931
Status:
COMPLETED
Last Update Posted:
2013-03-08
First Post:
2004-07-08
Brief Title:
Oxaliplatin Capecitabine and Radiation Therapy in Treating Patients With Locally Advanced Cancer of the Rectum
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase III Study of Weekly Intravenous Oxaliplatin in Combination With Oral Daily Capecitabine and Radiation Therapy in the Neoadjuvant Treatment of Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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 Drugs used in chemotherapy such as oxaliplatin and capecitabine 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 Oxaliplatin and capecitabine may make tumor cells more sensitive to radiation therapy and may kill more tumor cells Giving chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed
PURPOSE This phase III trial is studying the side effects and best dose of oxaliplatin and capecitabine when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for locally advanced cancer of the rectum NOTE The phase I portion of this trial closed 062005 The best dose of oxaliplatin and capecitabine has been determined
PURPOSE This phase III trial is studying the side effects and best dose of oxaliplatin and capecitabine when given together with radiation therapy and to see how well they work in treating patients who are undergoing surgery for locally advanced cancer of the rectum NOTE The phase I portion of this trial closed 062005 The best dose of oxaliplatin and capecitabine has been determined
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of neoadjuvant oxaliplatin and capecitabine when combined with radiotherapy in patients with locally advanced adenocarcinoma of the rectum Phase I closed to accrual as of 062005
Determine the rate of complete pathological response in patients treated with this regimen
Secondary
Determine the overall survival of patients treated with this regimen
Determine the rate of local and overall failure in patients treated with this regimen
Determine the utility of TS TP DPD ERCC-1 and apoptosis to predict response in patients treated with this regimen
Determine the rate of pathologic down-staging in patients treated with this regimen
Determine the safety and toxicity of this regimen in these patients
Determine the rate of sphincter-saving rectal surgery in patients treated with this regimen who had been deemed candidates for abdominoperineal resection at diagnosis
OUTLINE This is a multicenter phase I phase I closed to accrual as of 062005 dose-escalation study of oxaliplatin and capecitabine followed by a phase II study
Phase I closed to accrual as of 062005 Patients undergo radiotherapy once daily 5 days a week for 55 weeks and receive oral capecitabine twice daily on days radiotherapy is administered Beginning on day 1 of radiotherapy patients also receive oxaliplatin IV over 2 hours on days 1 8 15 22 and 29
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients undergo radiotherapy and receive capecitabine and oxaliplatin as in phase I at the MTD
All patients undergo curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy
Patients are followed every 3 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 31-40 patients 6-15 for phase I phase I closed to accrual as of 062005 and 25 for phase II will be accrued for this study within 2 years
Primary
Determine the maximum tolerated dose of neoadjuvant oxaliplatin and capecitabine when combined with radiotherapy in patients with locally advanced adenocarcinoma of the rectum Phase I closed to accrual as of 062005
Determine the rate of complete pathological response in patients treated with this regimen
Secondary
Determine the overall survival of patients treated with this regimen
Determine the rate of local and overall failure in patients treated with this regimen
Determine the utility of TS TP DPD ERCC-1 and apoptosis to predict response in patients treated with this regimen
Determine the rate of pathologic down-staging in patients treated with this regimen
Determine the safety and toxicity of this regimen in these patients
Determine the rate of sphincter-saving rectal surgery in patients treated with this regimen who had been deemed candidates for abdominoperineal resection at diagnosis
OUTLINE This is a multicenter phase I phase I closed to accrual as of 062005 dose-escalation study of oxaliplatin and capecitabine followed by a phase II study
Phase I closed to accrual as of 062005 Patients undergo radiotherapy once daily 5 days a week for 55 weeks and receive oral capecitabine twice daily on days radiotherapy is administered Beginning on day 1 of radiotherapy patients also receive oxaliplatin IV over 2 hours on days 1 8 15 22 and 29
Cohorts of 3-6 patients receive escalating doses of oxaliplatin and capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Patients undergo radiotherapy and receive capecitabine and oxaliplatin as in phase I at the MTD
All patients undergo curative-intent surgery 6-8 weeks after the completion of chemoradiotherapy
Patients are followed every 3 months for 3 years and then every 6 months for 2 years
PROJECTED ACCRUAL A total of 31-40 patients 6-15 for phase I phase I closed to accrual as of 062005 and 25 for phase II will be accrued for this study within 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| SANOFI-RPCI-I-10803 | None | None | None |
| RPCI-I-10803 | None | None | None |