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NCT01150045 · ClinicalTrials.gov registry record · Phase 3
Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 2,527
- Enrollment target
NCT01150045: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT01150045 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 2,527 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (227% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01150045, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,527 participants
- Enrollment target
Study 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.
Primary Outcome
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 stratifi
Interventions
- OTHER placebo
- DRUG 5-fluorouracil
- DRUG oxaliplatin
- DRUG leucovorin
- DRUG celecoxib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,527 participants |
| Start Date | 2010-06 |
| Est. Completion | 2022-08-11 |
| Phase | Phase 3 |
What the finished NCT01150045 record still lists
NCT01150045 is an interventional study that assigns participants to a tested intervention. Its 2,527 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (227% higher).
The record links to 0 conditions, and to 5 interventions - of which placebo is the first listed.
NCT01150045 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01150045 about?
NCT01150045 is a clinical study titled "Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery". 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 ...
What is the current status of trial NCT01150045?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,527 participants. The study started on 2010-06. Estimated completion is 2022-08-11.
What interventions are being tested in trial NCT01150045?
The interventions under investigation include: placebo (OTHER), 5-fluorouracil (DRUG), oxaliplatin (DRUG), leucovorin (DRUG), celecoxib (DRUG).
Who is sponsoring clinical trial NCT01150045?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01150045's enrollment target sits among peer trials
2,527 87th of 2000 higher than 1,914 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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