Ignite Creation Date:
2024-05-05 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00427570
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2007-01-18
Brief Title:
Fluorouracil Semustine and Vincristine Compared With BCG in Treating Patients With Dukes B or Dukes C Colon Cancer That Has Been Removed By Surgery
Sponsor:
NSABP Foundation Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Clinical Trial to Evaluate Postoperative Immunotherapy and Postoperative Systemic Chemotherapy in the Management of Resectable Colon Cancer
Status:
COMPLETED
Status Verified Date:
2010-08
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 vincristine fluorouracil and semustine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Biological therapies such as BCG may stimulate the immune system in different ways and stop tumor cells from growing It is not yet known whether combination chemotherapy is more effective than BCG in treating colon cancer that has been removed by surgery
PURPOSE This randomized phase III clinical trial is studying giving fluorouracil together with semustine and vincristine to see how well they work compared with giving BCG in treating patients with Dukes B or Dukes C colon cancer that has been removed by surgery
PURPOSE This randomized phase III clinical trial is studying giving fluorouracil together with semustine and vincristine to see how well they work compared with giving BCG in treating patients with Dukes B or Dukes C colon cancer that has been removed by surgery
Detailed Description:
OBJECTIVES I Obtain information to define subsets of colon cancer patients at high risk of recurrence II Correlate pathologic and biologic parameters with disease-free interval and survival III Determine the value of surgical and ancillary techniques in management of colon cancer IV Compare disease-free interval and survival after curative resection vs chemotherapy with 5-fluorouracilmethyl-CCNUvincristine vs BCG immunotherapy V Relate the total lymphocyte count to the course of the disease VI Determine the feasibility of conducting a trial employing immunotherapy in a surgical adjuvant setting VII Identify appropriate future protocols based on data generated in the study
OUTLINE Randomized study for patients with Dukes Stage B and C disease only All patients with Dukes A and D lesions enter Arm I Arm I No therapy following surgery Arm II 3-Drug Combination Chemotherapy 5-Fluorouracil 5-FU NSC-19893 Methyl-CCNU MeCCNU NSC-95441 Vincristine VCR NSC-67574 Arm III Immunotherapy BCG-Pasteur BCG NSC-B116328
PROJECTED ACCRUAL Protocol closed February 1984
OUTLINE Randomized study for patients with Dukes Stage B and C disease only All patients with Dukes A and D lesions enter Arm I Arm I No therapy following surgery Arm II 3-Drug Combination Chemotherapy 5-Fluorouracil 5-FU NSC-19893 Methyl-CCNU MeCCNU NSC-95441 Vincristine VCR NSC-67574 Arm III Immunotherapy BCG-Pasteur BCG NSC-B116328
PROJECTED ACCRUAL Protocol closed February 1984
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 |
|---|---|---|---|
| NSABP-C-01 | None | None | None |