Mucinous Adenocarcinoma of the Colon Clinical Trial
Official title:
Phase III Randomized Study of Adjuvant Immunotherapy With Monoclonal Antibody 17-1A Versus No Adjuvant Therapy Following Resection for State II (Modified Astler-Coller B2) Adenocarcinoma of the Colon
Verified date | June 2013 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Randomized phase III trial to compare the effectiveness of surgery with or without monoclonal antibody therapy in treating patients who have stage II colon cancer. Monoclonal antibodies such as edrecolomab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether surgery to remove colon cancer is more effect with or without monoclonal antibody therapy.
Status | Completed |
Enrollment | 2100 |
Est. completion date | |
Est. primary completion date | July 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Pathologic documentation of adenocarcinoma of the colon with or without penetration of the serosa with no lymph node metastases (Stage II pT3N0 or pT4bNO lesions, excluding pT4aN0; Modified Astler-Coller Stage B2); there can be no distant metastases or penetration of adjacent organs or structures; proximal, distal, and radial margins must be free of tumor Important note: A tumor nodule > 3 mm in diameter in the perirectal or pericolonic adipose tissue without histologic evidence of residual node in the nodule is classified as regional/pericolonic node metastasis; however, a tumor nodule =< 3 mm in diameter is classified in the T category as discontinuous extension (i.e., pT3); multiple metastatic foci seen microscopically only in the pericolonic fat should be considered as metastasis in a single lymph node for classification; although six or more nodes evaluated from the specimen is optimal, a minimum of three nodes (periodic or mesenteric) for evaluation is required for inclusion in the study - Complete, en bloc resection of all the primary tumor, performed as an open procedure, and not laparoscopically or laparoscopically assisted - No evidence of perforation or clinical obstruction of the bowel - The gross distal margin of the primary tumor must lie above the peritoneal reflection (i.e., it must be a colon, not a rectal cancer) - No previous radiation or chemotherapy for this malignancy - CALGB Performance status 0-1 - No concurrent treatment with systemic steroids is allowed; patients receiving replacement steroids for adrenal insufficiency are eligible; patients receiving inhaled steroids in daily doses of 500mg or less and patients being treated with topical steroids are eligible - No prior exposure to murine antibodies (e.g., diagnostic tests like the "oncoscint scan") - No uncontrolled or severe cardiovascular disease - No history of pancreatitis - Non-pregnant and non-lactating; patients of child-bearing potential should agree to use an effective method of birth control - No previous or concurrent malignancy is allowed, except inactive non-melanoma skin cancer, in situ carcinoma of the cervix, or other cancer if the patient has been disease-free for >= 5 years; patients with more than one synchronous primary colon tumor are eligible; for the purpose of this protocol, staging classification will be based on the stage of the more advanced primary tumor - Granulocytes > 1,800/µl - Platelet count > 100,000/µl - BUN < 1.5 x normal - Creatinine < 1.5 x normal - Bilirubin < 1.5 x normal |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Cancer and Leukemia Group B | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Survival | Estimated using the Kaplan-Meier method. Compared using the logrank test. | From time of randomization to death from any cause, assessed up to 5 years | No |
Secondary | Disease-free intervals | Estimated using the Kaplan-Meier method. Compared using the logrank test. | From time of randomization to colon cancer recurrence where deaths without recurrence will be censored at the time of death, assessed up to 5 years | No |
Secondary | Disease-free survival | Estimated using the Kaplan-Meier method. Compared using the logrank test. | From time of randomization to colon cancer recurrence or death from any cause, assessed up to 5 years | No |
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