Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003422
Status:
COMPLETED
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Radiation Therapy Before Surgery Compared With Chemotherapy Plus Radiation After Surgery in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Sponsor:
Medical Research Council
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomised Trial Comparing Pre-Operative Radiotherapy and Selective Post-Operative Chemoradiotherapy in Rectal Cancer
Status:
COMPLETED
Status Verified Date:
2007-03
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 Radiation therapy uses high-energy x-rays to damage tumor cells Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die It is not yet known whether giving radiation therapy before surgery is more effective than giving chemotherapy plus radiation therapy after surgery in treating patients with rectal cancer
PURPOSE This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed
PURPOSE This randomized phase III trial is studying radiation therapy given before surgery to see how well it works compared to chemotherapy and radiation therapy given after surgery in treating patients with rectal cancer that can be surgically removed
Detailed Description:
OBJECTIVES
Compare local recurrence free rates and quality of life in patients with operable rectal cancer receiving preoperative radiotherapy versus patients receiving selective postoperative chemoradiotherapy
Determine local recurrence free survival overall survival time to appearance of distant metastases disease free survival and morbidity in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by a number of factors including surgeon
Patients are randomized to receive preoperative radiotherapy arm I or postoperative chemoradiotherapy arm II
Arm I Patients receive radiotherapy in 5 fractions over 1 week prior to surgery Patients undergo surgery within 7 days of the last fraction of radiotherapy
Arm II Patients receive chemoradiotherapy 4-12 weeks after surgery if circumferential resection margins are histologically involved by tumor Radiotherapy is administered in 25 fractions over 5 weeks 5 days per week During radiotherapy patients either receive fluorouracil 5-FU continuous infusion 5-FU bolus IV and leucovorin calcium IV weekly or a 5-day bolus schedule of 5-FU and leucovorin calcium
Patients may then receive adjuvant chemotherapy as per local policy
Quality of life assessments are made every 3 months for 1 year and then every 6 months for the next 2 years
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1800 patients will be accrued into this study
Compare local recurrence free rates and quality of life in patients with operable rectal cancer receiving preoperative radiotherapy versus patients receiving selective postoperative chemoradiotherapy
Determine local recurrence free survival overall survival time to appearance of distant metastases disease free survival and morbidity in these patients
OUTLINE This is a randomized multicenter study Patients are stratified by a number of factors including surgeon
Patients are randomized to receive preoperative radiotherapy arm I or postoperative chemoradiotherapy arm II
Arm I Patients receive radiotherapy in 5 fractions over 1 week prior to surgery Patients undergo surgery within 7 days of the last fraction of radiotherapy
Arm II Patients receive chemoradiotherapy 4-12 weeks after surgery if circumferential resection margins are histologically involved by tumor Radiotherapy is administered in 25 fractions over 5 weeks 5 days per week During radiotherapy patients either receive fluorouracil 5-FU continuous infusion 5-FU bolus IV and leucovorin calcium IV weekly or a 5-day bolus schedule of 5-FU and leucovorin calcium
Patients may then receive adjuvant chemotherapy as per local policy
Quality of life assessments are made every 3 months for 1 year and then every 6 months for the next 2 years
Patients are followed every 3 months for 1 year every 6 months for 2 years and then annually thereafter
PROJECTED ACCRUAL Approximately 1800 patients will be accrued into this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISRCTN28785842 | None | None | None |
| MRC-CR07 | None | None | None |
| EU-98008 | None | None | None |
| CAN-NCIC-C016 | None | None | None |