Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003063
Status:
UNKNOWN
Last Update Posted:
2013-09-20
First Post:
1999-11-01
Brief Title:
Biological Therapy With Combination Chemotherapy in Patients With Colorectal Cancer
Sponsor:
European Institute of Oncology
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Adjuvant Chemoimmunotherapy for Colorectal Cancer
Status:
UNKNOWN
Status Verified Date:
2005-11
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Combining chemotherapy with biological therapy may kill more tumor cells
PURPOSE Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer
PURPOSE Randomized phase III trial to compare the effectiveness of treatment using levamisole with treatment using interferon alfa and combination chemotherapy consisting of fluorouracil and leucovorin in patients with stage II or stage III colorectal cancer
Detailed Description:
OBJECTIVES
Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium folinic acid as an adjuvant treatment of intraperitoneal colorectal cancer
OUTLINE This is a three arm study Patients are randomized to receive either levamisole alfa interferon or no treatment
Arm I Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery Fluorouracil IV bolus and leucovorin calcium folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery
Arm II Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery
Arm III Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles
Patients are followed every 3 months for 2 years then every 6 months
PROJECTED ACCRUAL 350 patients per arm will be accrued for a total of 1050 patients
Assess the efficacy of the addition of levamisole or alfa interferon to fluorouracil and leucovorin calcium folinic acid as an adjuvant treatment of intraperitoneal colorectal cancer
OUTLINE This is a three arm study Patients are randomized to receive either levamisole alfa interferon or no treatment
Arm I Patients receive levamisole PO for 3 days every 2 weeks for 6 months before and after surgery Fluorouracil IV bolus and leucovorin calcium folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery
Arm II Patients receive alfa interferon-2a SC on 3 alternate days for a week before surgery and for 6 months after surgery Fluorouracil IV bolus and folinic acid IV over 1 hour are administered on days 1-5 every 4 weeks for 6 cycles after surgery
Arm III Patients undergo surgery followed by fluorouracil IV bolus and folinic acid IV over 1 hour on days 1-5 every 4 weeks for 6 cycles
Patients are followed every 3 months for 2 years then every 6 months
PROJECTED ACCRUAL 350 patients per arm will be accrued for a total of 1050 patients
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 |
|---|---|---|---|
| EU-97011 | None | None | None |
| CNR-TONE-01 | None | None | None |