Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002523
Status:
COMPLETED
Last Update Posted:
2016-09-02
First Post:
1999-11-01
Brief Title:
Radiation Therapy Surgery and Chemotherapy in Treating Patients With Rectal Cancer That Can Be Surgically Removed
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
FOUR ARMS PHASE III CLINICAL TRIAL FOR T3-T4 RESECTABLE RECTAL CANCER COMPARING PRE-OPERATIVE PELVIC IRRADIATION TO PRE-OPERATIVE IRRADIATION COMBINED WITH FLUOROURACIL AND LEUCOVORIN WITH OR WITHOUT POST-OPERATIVE ADJUVANT CHEMOTHERAPY
Status:
COMPLETED
Status Verified Date:
2016-09
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug giving the drugs in different ways and combining radiation therapy and surgery with chemotherapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed
PURPOSE Randomized phase III trial to compare radiation therapy alone before surgery with radiation therapy plus fluorouracil and leucovorin before surgery with and without fluorouracil and leucovorin after surgery in patients with rectal cancer that can be surgically removed
Detailed Description:
OBJECTIVES
Compare the disease-free and overall survival in patients with resectable adenocarcinoma of the rectum treated with preoperative radiotherapy with or without preoperative fluorouracil 5-FU combined with leucovorin calcium CF andor postoperative 5-FUCF
OUTLINE This is a randomized multicenter study Patients are stratified according to center sex tumor location 0-5 vs 6-10 vs 11-15 cm from anal margin and stage T3 vs T4 Patients are randomized to 1 of 4 treatment arms
Arm I Patients undergo involved-field radiotherapy 5 days a week for 5 weeks followed 3-10 weeks later by abdominoperineal resection or anal-sparing resection according to local practice in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy as in arm I beginning on day 1 and leucovorin calcium CF IV followed by fluorouracil 5-FU IV 1 hour before radiotherapy on days 1-5 and 29-33 followed 3-10 weeks later by resection as in arm I in the absence of disease progression or unacceptable toxicity
Arm III Patients undergo radiotherapy followed 3-10 weeks later by resection as in arm I Within 3-10 weeks after resection patients receive CF followed by 5-FU on days 1-5 Chemotherapy continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm IV Patients undergo preoperative radiotherapy with concurrent chemotherapy followed by resection as in arm II and postoperative chemotherapy as in arm III
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 992 patients will be accrued for this study within 4 years
Compare the disease-free and overall survival in patients with resectable adenocarcinoma of the rectum treated with preoperative radiotherapy with or without preoperative fluorouracil 5-FU combined with leucovorin calcium CF andor postoperative 5-FUCF
OUTLINE This is a randomized multicenter study Patients are stratified according to center sex tumor location 0-5 vs 6-10 vs 11-15 cm from anal margin and stage T3 vs T4 Patients are randomized to 1 of 4 treatment arms
Arm I Patients undergo involved-field radiotherapy 5 days a week for 5 weeks followed 3-10 weeks later by abdominoperineal resection or anal-sparing resection according to local practice in the absence of disease progression or unacceptable toxicity
Arm II Patients undergo radiotherapy as in arm I beginning on day 1 and leucovorin calcium CF IV followed by fluorouracil 5-FU IV 1 hour before radiotherapy on days 1-5 and 29-33 followed 3-10 weeks later by resection as in arm I in the absence of disease progression or unacceptable toxicity
Arm III Patients undergo radiotherapy followed 3-10 weeks later by resection as in arm I Within 3-10 weeks after resection patients receive CF followed by 5-FU on days 1-5 Chemotherapy continues every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
Arm IV Patients undergo preoperative radiotherapy with concurrent chemotherapy followed by resection as in arm II and postoperative chemotherapy as in arm III
Patients are followed every 6 months
PROJECTED ACCRUAL A total of 992 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| EORTC-22921 | None | None | None |