Study Summary
This trial is studying oxaliplatin, leucovorin calcium, and fluorouracil given together with or without celecoxib in treating patients with stage III colon cancer previously treated with surgery.
Eligible Conditions
- Colorectal Cancer
Treatment Effectiveness
Effectiveness Progress
This is further along than 85% of similar trials
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: At 3 years of follow-up
Year 3
Disease-free Survival
Year 3
Overall Survival
Trial Safety
Safety Progress
This is further along than 85% of similar trials
Side Effects for
Experimental: Phase I/II: Celecoxib 400mg BID + RT
36%Fatigue (lethargy, malaise, asthenia)
27%Radiation dermatitis
18%Nausea
9%Hemoglobin (Hgb)
9%Confusion
9%Dysphagia-esophageal related to radiation
9%Weight loss
9%Infection without neutropenia
9%Edema
9%Vomiting
9%Late RT Toxicity: Lung
9%Anorexia
9%Headache
9%Cough
9%Pleuritic pain
Trial Design
4 Treatment Groups
Arm C - FOLFOX and placebo (6 treatments)
1 of 4
Arm A - FOLFOX and placebo (12 treatments)
1 of 4
Arm D - FOLFOX and celecoxib (6 treatments)
1 of 4
Arm B - FOLFOX and celecoxib (12 treatments)
1 of 4
Active Control
Experimental Treatment
2527 Total Participants · 4 Treatment Groups
Primary Treatment: celecoxib · Has Placebo Group · Phase 3
Arm D - FOLFOX and celecoxib (6 treatments)Experimental Group · 4 Interventions: 5-fluorouracil, oxaliplatin, leucovorin, celecoxib · Intervention Types: Drug, Drug, Drug, Drug
Arm B - FOLFOX and celecoxib (12 treatments)Experimental Group · 4 Interventions: 5-fluorouracil, oxaliplatin, leucovorin, celecoxib · Intervention Types: Drug, Drug, Drug, Drug
Arm C - FOLFOX and placebo (6 treatments)ActiveComparator Group · 4 Interventions: 5-fluorouracil, placebo, oxaliplatin, leucovorin · Intervention Types: Drug, Other, Drug, Drug
Arm A - FOLFOX and placebo (12 treatments)ActiveComparator Group · 4 Interventions: 5-fluorouracil, placebo, oxaliplatin, leucovorin · Intervention Types: Drug, Other, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Leucovorin
FDA approved
Celecoxib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 years of follow-up
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,068 Previous Clinical Trials
41,126,775 Total Patients Enrolled
Alliance for Clinical Trials in OncologyLead Sponsor
502 Previous Clinical Trials
213,045 Total Patients Enrolled
Jeffrey Meyerhardt, MD, MPHStudy ChairDana-Farber Cancer Institute
3 Previous Clinical Trials
335 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Patients with node positive disease (N1 or N2) as designated in AJCC version 7.
Patients with synchronous colon and rectal primary tumors are eligible and staging for stratification will be based on higher N stage of the more advanced primary tumor
You have no evidence of residual involved lymph node disease or metastatic disease at the time of registration.
Who else is applying?
What state do they live in?
| Nova Scotia | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| PEI Cancer Treatment Centre-Queen Elizabeth Hospital | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
References
- Meyerhardt, Jeffrey A., Qian Shi, Charles S. Fuchs, Jeffrey Meyer, Donna Niedzwiecki, Tyler Zemla, Priya Kumthekar, et al.. 2021. “Effect of Celecoxib Vs Placebo Added to Standard Adjuvant Therapy on Disease-free Survival Among Patients with Stage III Colon Cancer”. Jama. American Medical Association (AMA). doi:10.1001/jama.2021.2454.
- Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, André T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2022 Oct 28:JCO2102726. doi: 10.1200/JCO.21.02726. [Epub ahead of print]
- Lee S, Ma C, Shi Q, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF, Meyerhardt JA. Potential Mediators of Oxaliplatin-Induced Peripheral Neuropathy From Adjuvant Therapy in Stage III Colon Cancer: Findings From CALGB (Alliance)/SWOG 80702. J Clin Oncol. 2022 Nov 11:JCO2201637. doi: 10.1200/JCO.22.01637. [Epub ahead of print]
- Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2022 Oct 28:JCO2102726. doi: 10.1200/JCO.21.02726. Online ahead of print.
- Lee S, Ma C, Shi Q, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF, Meyerhardt JA. Potential Mediators of Oxaliplatin-Induced Peripheral Neuropathy From Adjuvant Therapy in Stage III Colon Cancer: Findings From CALGB (Alliance)/SWOG 80702. J Clin Oncol. 2022 Nov 11:JCO2201637. doi: 10.1200/JCO.22.01637. Online ahead of print.
- 2010. "Oxaliplatin, Leucovorin Calcium, and Fluorouracil With or Without Celecoxib in Treating Patients With Stage III Colon Cancer Previously Treated With Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01150045.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments