Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002896
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Chemotherapy Before Surgery With or Without Chemotherapy After Surgery in Treating Patients With Rectal Cancer
Sponsor:
European Institute of Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
RANDOMIZED TRIAL OF CONCOMITANT PREOPERATIVE RADIO-CHEMOTHERAPY WITH OR WITHOUT POSTOPERATIVE CHEMOTHERAPY IN LOCALLY ADVANCED RECTAL CARCINOMA
Status:
UNKNOWN
Status Verified Date:
2008-02
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 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 chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin after surgery in patients with locally advanced rectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of radiation therapy plus fluorouracil and leucovorin before surgery given with or without fluorouracil and leucovorin after surgery in patients with locally advanced rectal cancer
Detailed Description:
OBJECTIVES I Assess the local recurrence rate cost-benefit ratio and acute and late toxicity associated with concomitant preoperative radiotherapy and fluorouracilleucovorin 5-FUCF in patients with locally advanced adenocarcinoma of the rectum II Compare the relapse rate survival rate disease-free interval and cost-benefit ratio associated with 6 courses of postoperative 5-FUCF vs no further treatment in these patients
OUTLINE This is a randomized study Patients are stratified by tumor stage age type of surgery and participating institution Patients are randomly assigned to one of two groups The first group receives radiotherapy to the tumor over 5 weeks and concomitant fluorouracilleucovorin for 5 consecutive days on the first and fifth weeks Four to six weeks later patients undergo complete resection followed upon recovery by fluorouracilleucovorin every 4 weeks for 6 courses The second group receives preoperative chemoradiotherapy followed by surgery as above with no postoperative treatment Patients are followed for survival
PROJECTED ACCRUAL A total of 774 patients will be entered on this multicenter study
OUTLINE This is a randomized study Patients are stratified by tumor stage age type of surgery and participating institution Patients are randomly assigned to one of two groups The first group receives radiotherapy to the tumor over 5 weeks and concomitant fluorouracilleucovorin for 5 consecutive days on the first and fifth weeks Four to six weeks later patients undergo complete resection followed upon recovery by fluorouracilleucovorin every 4 weeks for 6 courses The second group receives preoperative chemoradiotherapy followed by surgery as above with no postoperative treatment Patients are followed for survival
PROJECTED ACCRUAL A total of 774 patients will be entered on this multicenter 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 |
|---|---|---|---|
| CNR-9604 | None | None | None |
| EU-96047 | None | None | None |