Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00425152
Status:
COMPLETED
Last Update Posted:
2010-02-08
First Post:
2007-01-18
Brief Title:
Fluorouracil and Leucovorin andor Levamisole After Surgery In Treating Patients With Dukes B Or Dukes C Colon Cancer
Sponsor:
NSABP Foundation Inc
Organization:
NSABP Foundation Inc
Study Overview
Official Title:
A Clinical Trial to Assess the Relative Efficacy of 5-FU Leucovorin 5-FU Levamisole and 5-FU Leucovorin Levamisole in Patients With Dukes B and C Carcinoma of the Colon
Status:
COMPLETED
Status Verified Date:
2010-02
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 such as fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Leucovorin may help fluorouracil kill more tumor cells Biological therapies such as levamisole may interfere with the growth of tumor cells and slow the growth of solid tumors It is not yet known whether fluorouracil is more effective when given together with leucovorin andor levamisole after surgery in treating colon cancer
PURPOSE This randomized phase III trial is studying giving fluorouracil together with leucovorin to see how well it works compared with giving fluorouracil together with levamisole or giving fluorouracil together with leucovorin and levamisole after surgery in treating patients with Dukes B or Dukes C colon cancer
PURPOSE This randomized phase III trial is studying giving fluorouracil together with leucovorin to see how well it works compared with giving fluorouracil together with levamisole or giving fluorouracil together with leucovorin and levamisole after surgery in treating patients with Dukes B or Dukes C colon cancer
Detailed Description:
OBJECTIVES I Compare in a Phase III setting disease-free survival and overall survival of patients who have undergone potentially curative resection of Dukes B or C carcinoma of the colon randomly assigned to adjuvant therapy with 5-fluorouracilleucovorin vs 5-fluorouracillevamisole vs 5-fluorouracilleucovorinlevamisole
OUTLINE Randomized study Arm I Single-agent Chemotherapy with Drug Modulation 5-Fluorouracil 5-FU NSC-19893 with Leucovorin calcium Citrovorum Factor CF NSC-3590 Arm II Single-agent Chemotherapy with Drug Modulation plus Biological Response Modifier Therapy 5-FU with CF plus Levamisole LEV NSC-177023 Arm III Single-agent Chemotherapy plus Biological Response Modifier Therapy 5-FU plus LEV
PROJECTED ACCRUAL 1800 evaluable patients will be accrued over about 3 years an additional 2 years will be required before final analysis
OUTLINE Randomized study Arm I Single-agent Chemotherapy with Drug Modulation 5-Fluorouracil 5-FU NSC-19893 with Leucovorin calcium Citrovorum Factor CF NSC-3590 Arm II Single-agent Chemotherapy with Drug Modulation plus Biological Response Modifier Therapy 5-FU with CF plus Levamisole LEV NSC-177023 Arm III Single-agent Chemotherapy plus Biological Response Modifier Therapy 5-FU plus LEV
PROJECTED ACCRUAL 1800 evaluable patients will be accrued over about 3 years an additional 2 years will be required before final analysis
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 |
|---|---|---|---|
| NCOG-NSABP-C-04 | US NIH GrantContract | None | httpsreporternihgovquickSearchU10CA012027 |
| U10CA012027 | NIH | None | None |