Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005944
Status:
TERMINATED
Last Update Posted:
2021-02-17
First Post:
2000-07-05
Brief Title:
Second-look Surgery With or Without Intraperitoneal Chemotherapy in Treating Patients With Recurrent Colorectal Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Study of Second Look Surgery With or Without Chemotherapy Intraperitoneally in the Event of Risk of Intraperitoneal Recurrence
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
insuffisient recruitment
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 Giving chemotherapy drugs in different ways may kill more tumor cells
PURPOSE Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum
PURPOSE Randomized phase II trial to compare the effectiveness of second-look surgery with or without intraperitoneal infusions of mitomycin and fluorouracil in treating patients who have colorectal cancer that is recurrent to the peritoneum
Detailed Description:
OBJECTIVES I Compare the effect of second look surgery with or without intraperitoneal mitomycin and fluorouracil on the 3 year survival rate of patients with colorectal cancer who are at high risk for peritoneal cavity cancer II Compare the quality of life of patients treated with these regimens III Compare the toxicity of these regimens in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to center risk group presence of symptoms yes vs no and isolated disease yes vs no After primary surgery all patients receive 6 months of chemotherapy consisting of leucovorin calcium IV followed by fluorouracil IV over 10 minutes on days 1-5 every 4 weeks Patients then undergo second look surgery or laparoscopy at 8-12 months Second look surgery or laparoscopy may be performed earlier if markers increase progressively for unknown reasons or symptoms of peritoneal cancer occur Patients with recurrent disease that can be resected are randomized to one of two treatment arms Patients with no residual disease or with unresectable disease are followed for survival Arm I Patients undergo complete resection of all detectable lesions followed immediately by intraperitoneal IP mitomycin on day 0 and fluorouracil IP on days 1-4 Patients also receive systemic chemotherapy consisting of leucovorin calcium IV over 2 hours and fluorouracil IV bolus followed by fluorouracil IV over 22 hours on days 1 and 2 Systemic chemotherapy repeats every 2 weeks for 6 months Arm II Patients undergo complete or partial resection and then receive systemic chemotherapy as in arm I Quality of life is assessed at baseline and then every 4 months for 3 years All patients including nonrandomized patients are followed every 4 months for 3 years
PROJECTED ACCRUAL A total of 152 patients 76 randomized will be accrued for this study
OUTLINE This is a randomized multicenter study Patients are stratified according to center risk group presence of symptoms yes vs no and isolated disease yes vs no After primary surgery all patients receive 6 months of chemotherapy consisting of leucovorin calcium IV followed by fluorouracil IV over 10 minutes on days 1-5 every 4 weeks Patients then undergo second look surgery or laparoscopy at 8-12 months Second look surgery or laparoscopy may be performed earlier if markers increase progressively for unknown reasons or symptoms of peritoneal cancer occur Patients with recurrent disease that can be resected are randomized to one of two treatment arms Patients with no residual disease or with unresectable disease are followed for survival Arm I Patients undergo complete resection of all detectable lesions followed immediately by intraperitoneal IP mitomycin on day 0 and fluorouracil IP on days 1-4 Patients also receive systemic chemotherapy consisting of leucovorin calcium IV over 2 hours and fluorouracil IV bolus followed by fluorouracil IV over 22 hours on days 1 and 2 Systemic chemotherapy repeats every 2 weeks for 6 months Arm II Patients undergo complete or partial resection and then receive systemic chemotherapy as in arm I Quality of life is assessed at baseline and then every 4 months for 3 years All patients including nonrandomized patients are followed every 4 months for 3 years
PROJECTED ACCRUAL A total of 152 patients 76 randomized 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-20010 | None | None | None |
| FRE-FNCLCC-97018 | None | None | None |