Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006112
Status:
UNKNOWN
Last Update Posted:
2011-04-26
First Post:
2000-08-03
Brief Title:
Fluorouracil With or Without Mitomycin in Treating Patients With Peritoneal Cancer
Sponsor:
Gustave Roussy Cancer Campus Grand Paris
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Randomized Therapeutic Study Comparing Tumor Resection Followed Immediately by Intraperitoneal Chemotherapy and Systemic Chemotherapy VS Systemic Chemotherapy Alone for the Treatment of Colorectal Cancer Metastatic to the Peritoneum
Status:
UNKNOWN
Status Verified Date:
2001-05
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 may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer
PURPOSE Randomized phase II trial to compare the effectiveness of fluorouracil with or without mitomycin in treating patients who have peritoneal cancer
Detailed Description:
OBJECTIVES I Compare the efficacy of adjuvant systemic fluorouracil with intraperitoneal mitomycin vs systemic fluorouracil alone in terms of survival in patients with peritoneal cancer originating from the colorectum
OUTLINE This is a randomized multicenter study Patients are stratified according to center and mode of surgery Patients are randomized to one of two treatment arms Arm I Patients undergo complete resection of tumor on day 0 Patients then receive mitomycin intraperitoneally IP over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5 Patients then receive one of three systemic chemotherapy regimens for 6 months Regimen I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 Treatment repeats every 2 weeks Regimen II Patients receive fluorouracil IV continuously for 7 weeks Treatment repeats every 8 weeks Regimen III Leucovorin calcium and fluorouracil are administered as per standard procedure Arm II Patients receive treatment as in arm I but without early intraperitoneal chemotherapy Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL At least 90 patients 45 per arm will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to center and mode of surgery Patients are randomized to one of two treatment arms Arm I Patients undergo complete resection of tumor on day 0 Patients then receive mitomycin intraperitoneally IP over 23 hours on day 1 and fluorouracil IP over 24 hours on days 2-5 Patients then receive one of three systemic chemotherapy regimens for 6 months Regimen I Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV over 22 hours on days 1 and 2 Treatment repeats every 2 weeks Regimen II Patients receive fluorouracil IV continuously for 7 weeks Treatment repeats every 8 weeks Regimen III Leucovorin calcium and fluorouracil are administered as per standard procedure Arm II Patients receive treatment as in arm I but without early intraperitoneal chemotherapy Patients are followed every 3 months for 2 years
PROJECTED ACCRUAL At least 90 patients 45 per arm 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-20012 | None | None | None |
| FRE-IGR-95040434-SUGAR | None | None | None |