Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
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ClinicalTrials.gov Identifier: NCT01150045 |
Recruitment Status : Unknown
Verified March 2022 by Alliance for Clinical Trials in Oncology.
Recruitment status was: Active, not recruiting
First Posted : June 24, 2010
Results First Posted : August 6, 2021
Last Update Posted : March 22, 2022
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Tracking Information | ||||
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First Submitted Date ICMJE | June 23, 2010 | |||
First Posted Date ICMJE | June 24, 2010 | |||
Results First Submitted Date ICMJE | May 27, 2021 | |||
Results First Posted Date ICMJE | August 6, 2021 | |||
Last Update Posted Date | March 22, 2022 | |||
Study Start Date ICMJE | June 2010 | |||
Actual Primary Completion Date | February 28, 2020 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Disease-free Survival [ Time Frame: At 3 years of follow-up ] Disease-Free Survival (DFS) is defined as the time of randomization until documented progression or death from any cause. The endpoint of this trial is to compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 3 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive and disease free after 3 years are reported here. A log-rank test stratified with the stratification factors was used to compare disease-free survival (celecoxib vs placebo)
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Original Primary Outcome Measures ICMJE |
Disease-free survival | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
Overall Survival [ Time Frame: up to 3 years from registration ] Overall Survival (DFS) is defined as the time of randomization until documented death from any cause. The endpoint is to compare overall survival of patients with stage III colon cancer randomized to standard chemotherapy only (FOLFOX; Arm A and Arm C) or standard chemotherapy (FOLFOX) with 5 years of celecoxib 400 mg daily (Arm B and Arm D). The percentage of patients who were alive after 3 years are reported here.
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery | |||
Official Title ICMJE | A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer | |||
Brief Summary | PURPOSE: This randomized phase III trial is studying giving oxaliplatin, leucovorin calcium, and fluorouracil together to compare how well they work when given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery. RATIONALE: Drugs used in chemotherapy, such as oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving oxaliplatin, leucovorin calcium, and fluorouracil is more effective with or without celecoxib in treating colon cancer. |
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Detailed Description | OUTLINE: This is a multicenter study. Patients are stratified according to number of positive lymph nodes* (1-3 vs 4 or more) and concurrent regular low-dose of aspirin (yes vs no). Patients are randomized to 1 of 4 treatment arms. Please see the "Arms" section for more information. In all arms, treatment with celecoxib or placebo continues for 3 years in the absence of disease progression or unacceptable toxicity. Blood and tissue samples maybe collected for biomarker analysis and pharmacogenomic studies. The primary and secondary objectives for the research study are described below. Primary objective: 1. To compare disease-free survival of patients with stage III colon cancer randomized to standard chemotherapy only FOLFOX or standard chemotherapy FOLFOX with 3 years of celecoxib 400 mg daily. Secondary objectives:
After completion of study therapy, patients are followed up every 6 months for up to 6 years. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Colorectal Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Unknown status | |||
Actual Enrollment ICMJE |
2527 | |||
Original Estimated Enrollment ICMJE |
2500 | |||
Study Completion Date ICMJE | Not Provided | |||
Actual Primary Completion Date | February 28, 2020 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE |
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Puerto Rico, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01150045 | |||
Other Study ID Numbers ICMJE | CALGB-80702 U10CA031946 ( U.S. NIH Grant/Contract ) CALGB-80702 CDR0000675693 ( Registry Identifier: NCI Physician Data Query ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Alliance for Clinical Trials in Oncology | |||
Original Responsible Party | Monica M. Bertagnolli, Cancer and Leukemia Group B | |||
Current Study Sponsor ICMJE | Alliance for Clinical Trials in Oncology | |||
Original Study Sponsor ICMJE | Cancer and Leukemia Group B | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | Alliance for Clinical Trials in Oncology | |||
Verification Date | March 2022 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |