Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00058474
Status:
UNKNOWN
Last Update Posted:
2016-03-23
First Post:
2003-04-07
Brief Title:
Radiation Therapy and Either Capecitabine or Fluorouracil With or Without Oxaliplatin Before Surgery in Treating Patients With Resectable Rectal Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
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
Status Verified Date:
2016-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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
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 eg 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 1606 patients will be accrued for this study within 4 years
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 eg 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 1606 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| CALGB-NSABP-R-04 | None | None | None |
| NSABP-R-04 | None | None | None |