Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296608
Status:
COMPLETED
Last Update Posted:
2016-05-30
First Post:
2006-02-24
Brief Title:
Radiation Therapy With or Without Chemotherapy Before Surgery in Treating Patients With Stage II or Stage III Rectal Cancer
Sponsor:
Federation Francophone de Cancerologie Digestive
Organization:
Federation Francophone de Cancerologie Digestive
Study Overview
Official Title:
Preoperative Radiotherapy With or Without Concurrent Chemotherapy 5-Fluorouracil and Leucovorin in T3-4 Rectal Cancers - Randomized Trial
Status:
COMPLETED
Status Verified Date:
2016-05
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 fluorouracil and leucovorin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving radiation therapy and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving chemotherapy after surgery may kill any tumor cells that remain after surgery It is not yet known whether radiation therapy is more effective with or without chemotherapy when given before surgery for rectal cancer
PURPOSE This randomized phase III trial is studying radiation therapy given together with fluorouracil and leucovorin to see how well they work compared to giving radiation therapy alone before surgery in treating patients with stage II or stage III rectal cancer
PURPOSE This randomized phase III trial is studying radiation therapy given together with fluorouracil and leucovorin to see how well they work compared to giving radiation therapy alone before surgery in treating patients with stage II or stage III rectal cancer
Detailed Description:
OBJECTIVES
Compare the recurrence-free and overall survival of patients with resectable stage II or III adenocarcinoma of the rectum treated with neoadjuvant radiotherapy with or without concurrent chemotherapy comprising fluorouracil and leucovorin calcium followed by surgery and adjuvant fluorouracil and leucovorin calcium
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to participating center gender location of the tumor relative to the anal margin 0-5 cm vs 5 cm and tumor stage T3 vs T4 Patients are randomized to 1 of 2 treatment arms
Neoadjuvant therapy Patients are randomized to 1 of 2 neoadjuvant therapy arms
Arm I Patients receive leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5 Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients also undergo concurrent radiotherapy 5 days a week for 5 weeks
Arm II Patients undergo radiotherapy as in arm I
Surgery In both arms patients undergo surgical resection within 3-10 weeks after completing neoadjuvant therapy
Adjuvant therapy Within 3-10 weeks after surgery all patients receive adjuvant chemotherapy comprising leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for at least 5 years
PROJECTED ACCRUAL A total of 762 patients will be accrued for this study
Compare the recurrence-free and overall survival of patients with resectable stage II or III adenocarcinoma of the rectum treated with neoadjuvant radiotherapy with or without concurrent chemotherapy comprising fluorouracil and leucovorin calcium followed by surgery and adjuvant fluorouracil and leucovorin calcium
OUTLINE This is a randomized controlled multicenter study Patients are stratified according to participating center gender location of the tumor relative to the anal margin 0-5 cm vs 5 cm and tumor stage T3 vs T4 Patients are randomized to 1 of 2 treatment arms
Neoadjuvant therapy Patients are randomized to 1 of 2 neoadjuvant therapy arms
Arm I Patients receive leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5 Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity Patients also undergo concurrent radiotherapy 5 days a week for 5 weeks
Arm II Patients undergo radiotherapy as in arm I
Surgery In both arms patients undergo surgical resection within 3-10 weeks after completing neoadjuvant therapy
Adjuvant therapy Within 3-10 weeks after surgery all patients receive adjuvant chemotherapy comprising leucovorin calcium IV and fluorouracil IV over 15 minutes on days 1-5 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months for at least 5 years
PROJECTED ACCRUAL A total of 762 patients will be accrued for this study
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 |
|---|---|---|---|
| EU-20600 | None | None | None |
| FFCD-9203 | None | None | None |