NCT01150045

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Official title

A Phase III Trial of 6 Versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients With Resected Stage III Colon Cancer

Phase

Phase 3

Status

Completed

Conditions

Colorectal Cancer

Interventions

celecoxib; 5-fluorouracil; placebo; oxaliplatin; leucovorin

Arms

• Arm A - FOLFOX and placebo (12 treatments) · Active comparator
• Arm B - FOLFOX and celecoxib (12 treatments) · Experimental
• Arm C - FOLFOX and placebo (6 treatments) · Active comparator
• Arm D - FOLFOX and celecoxib (6 treatments) · Experimental

Enrollment

2,527

Primary outcomes

• Disease-free Survival

Sponsor

Alliance for Clinical Trials in Oncology with National Cancer Institute (NCI)

Start

Jun 2010

Primary completion

Feb 28, 2020

Results posted

Yes

Registry record

NCT01150045 · updated May 19, 2026

• Zhang GQ, Meyerhardt JA, Shi Q, Twombly T, Pederson L, Ma C, Vayrynen JP, Zhao M, Takashima Y, Shergill A, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Tan B, O'Reilly EM, Giannakis M, Ogino S, Jurdi A, Sharma S, Aleshin A, Shields AF, Nowak JA. Predictive Role of Circulating Tumor DNA in Stage III Colon Cancer Treated With Celecoxib: A Post Hoc Analysis of the CALGB (Alliance)/SWOG 80702 Phase 3 Randomized Clinical Trial. JAMA Oncol. 2026 Feb 1;12(2):149-158. doi: 10.1001/jamaoncol.2025.5144. PubMed 41343176
• Nowak JA, Twombly T, Ma C, Shi Q, Haruki K, Fujiyoshi K, Vayrynen J, Zhao M, Knight J, Mane S, Shergill A, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Tan B, Philip P, O'Reilly EM, Shields AF, Ogino S, Fuchs CS, Meyerhardt JA. Improved Survival With Adjuvant Cyclooxygenase 2 Inhibition in PIK3CA-Activated Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance). J Clin Oncol. 2024 Aug 20;42(24):2853-2859. doi: 10.1200/JCO.23.01680. Epub 2024 Jun 18. PubMed 38889377
• Lee S, Ma C, Shi Q, Meyers J, Kumar P, Couture F, Kuebler P, Krishnamurthi S, Lewis D, Tan B, O'Reilly EM, Shields AF, Meyerhardt JA. Sleep and cancer recurrence and survival in patients with resected Stage III colon cancer: findings from CALGB/SWOG 80702 (Alliance). Br J Cancer. 2023 Aug;129(2):283-290. doi: 10.1038/s41416-023-02290-2. Epub 2023 May 13. PubMed 37179438
• Cheng E, Shi Q, Shields AF, Nixon AB, Shergill AP, Ma C, Guthrie KA, Couture F, Kuebler P, Kumar P, Tan B, Krishnamurthi SS, Ng K, O'Reilly EM, Brown JC, Philip PA, Caan BJ, Cespedes Feliciano EM, Meyerhardt JA. Association of Inflammatory Biomarkers With Survival Among Patients With Stage III Colon Cancer. JAMA Oncol. 2023 Mar 1;9(3):404-413. doi: 10.1001/jamaoncol.2022.6911. PubMed 36701146
• 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. 2023 Feb 10;41(5):1079-1091. doi: 10.1200/JCO.22.01637. Epub 2022 Nov 11. PubMed 36367997
• 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. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28. PubMed 36306483
• Meyerhardt JA, Shi Q, Fuchs CS, Meyer J, Niedzwiecki D, Zemla T, Kumthekar P, Guthrie KA, Couture F, Kuebler P, Bendell JC, Kumar P, Lewis D, Tan B, Bertagnolli M, Grothey A, Hochster HS, Goldberg RM, Venook A, Blanke C, O'Reilly EM, Shields AF. Effect of Celecoxib vs Placebo Added to Standard Adjuvant Therapy on Disease-Free Survival Among Patients With Stage III Colon Cancer: The CALGB/SWOG 80702 (Alliance) Randomized Clinical Trial. JAMA. 2021 Apr 6;325(13):1277-1286. doi: 10.1001/jama.2021.2454. PubMed 33821899