SWOG clinical trial number
CTSU/C80702

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

Closed
Phase
Abbreviated Title
Ph III Colon FOLFOX + Celecoxib/Placebo
Status Notes
This study will be permanently closed to accrual effective 11/20/15 at 4:30 P.M. E.S.T..
Activated
08/15/2010
Closed
11/20/2015
Participants
CTSU

Research committees

Gastrointestinal Cancer

Treatment

5-Fluorouracil Leucovorin Calcium Oxaliplatin Celecoxib Placebo

Eligibility Criteria Expand/Collapse

The Southwest Oncology Group has endorsed this study through the Cancer Trials Support Unit (CTSU) of the National Cancer Institute.

Please contact the CTSU directly by phone (888/823-5923) or on the CTSU website (http://www.ctsu.org/) for more information and registration procedures.

Publication Information Expand/Collapse

2024

Improved survival with adjuvant COX-2 inhibition in PIK3CA-activated stage III colon cancer

J Nowak;T Twombly;C Ma;Q Shi;K Haruki;K Fujiyoshi;J Vayrynen;M Zhao;J Knight;S Mane;P Kumar;F Couture;P Kuebler;S Krishnamurthi;B Tan;P Philip;E O'Reilly;A Shields;S Ogino;C Fuchs;J Meyerhardt Journal of Clinical Oncology Aug 20;42(24):2853-2859

PMid: PMID38889377

Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials

C Gallois;Q Shi;J Meyers;T Iveson;S Alberts;A De Gramont;A Sobrero;D Haller;E Oki;A Shields;R Goldberg;R Kerr;S Lonardi;G Yothers;C Kelly;I Boukovinas;R Labianca;F Sinicrope;I Souglakos;T Yoshino;J Meyerhardt;T Andre;D Papamichael;J Taieb Journal of Clinical Oncology Jul 1;42(19):2295-2305

PMid: PMID38547438

Oxaliplatin-Based Adjuvant Chemotherapy in Older Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 12 Trials

C Gallois;Q Shi;L Pedersen;T Andre;T Iveson;A Sobrero;S Alberts;A De Gramont;J Meyerhardt;T George;H Schmoll;I Souglakos;A Harkin;R Labianca;F Sinicrope;E Oki;A Shields;I Boukovinas;R Kerr;S Lonardi;G Yothers;T Yoshino;R Goldberg;J Taieb;D Papamichael Journal of Clinical Oncology Jul 1;42(19):2295-2305

PMid: PMID38547438

2023

Physical Activity in Stage III Colon Cancer: CALGB/SWOG 80702 (Alliance)

J Brown;C Ma;Q Shi;C Fuchs;J Meyer;D Niedzwiecki;T Zemla;F Couture;P Kuebler;P Kumar;D Lewis;B Tan;E O'Reilly;AF Shields;J Meyerhardt Journal of Clinical Oncology Jan 10;41(2):243-254

PMid: PMID35944235 | PMC number: PMC9839249

Sleep and cancer recurrence and survival in patients with resected Stage III colon cancer: findings from CALGB/SWOG 80702 (Alliance)

S Lee;C Ma;Q Shi;J Meyer;P Kumar;F Coutoure;P Kuebler;D Lewis;B Tan;E O'Reilly;A Shields;J Meyerhardt Br J Cancer, Aug;129(2):283-290

PMid: PMID37179438 | PMC number: PMC10338523

Associations of Inflammatory Biomarkers with Survival Among Patients with Stage III Colon Cancer (CALGB/SWOG 80702 [Alliance])

E Cheng;Q Shi;A Shields;A Nixon;R Nader;A Shergill;C Ma;K Guthrie;F Couture;P Kuebler;P Kumar;D Lewis;B Tan;S Krishnamurthi;K Ng;E O'Reilly;J Brown;P Philip;B Caan;E Feliciano;J Meyerhardt JAMA Oncology Mar 1;9(3):404-413

PMid: PMID36701146 | PMC number: PMC9880869

Potential Mediators of Oxaliplatin-Induced Peripheral Neuropathy from Adjuvant Therapy in Stage III Colon Cancer: Findings from CALGB/SWOG 80702 (Alliance)

S Lee;C Ma;Q Shi;P Kumar;F Coutoure;JP Kuebler;S Krishnamurthi;D Lewis;B Tan;R Goldberg;A Venook;CD Blanke;E O'Reilly;A Shields;J Meyerhardt Journal of Clinical Oncology Feb 10;41(5):1079-1091

PMid: PMID36367997 | PMC number: PMC9928634

Association between physical activity and the time course of cancer recurrence in stage III colon cancer

J Brown;C Ma;D Niedzwiecki;T Zemla;F Couture;P Kuebler;P Kumar;J Hopkins;B Tan;S Krishnamurthi;E O'Reilly;A Shields;J Meyerhardt Br J Sports Med. Aug;57(15):965-971

PMid: PMID36878665 | PMC number: PMC19423490

Plasma 25-Hydroxyvitamin D Levels and Survival in Stage III Colon Cancer: Findings from CALGB/SWOG 80702 (Alliance)

Q Wang;C Ma;Q Shi;B Wolpin;Y Zhang;C Fuchs;J Meyer;T Zemla;P Kumthekar;K Guthrie;F Couture;P Kuebler;P Kumar;B Tan;S Krishnamurthi;R Goldberg;A Venook;C Blanke;A Shields;E O'Reilly;J Meyerhardt;K Ng Clin Cancer Res. Jul 14;29(14):2621-2630

PMid: PMID37289007 | PMC number: PMC10524689

2022

Associations of Inflammatory Biomarkers with Survival Among Patients with Stage III Colon Cancer (CALGB/SWOG 80702 [Alliance])

E Cheng;Q Shi;A Shields;N Rifai;E Feliciano;J Meyers;A Nixon;A Shegrill;K Guthrie;F Couture;P Kuebler;J Bendell;P Kumar;D Lewis;B Tan;E O'Reilly;J Brown;P Philip;B Caan;J Meyerhardt American Association for Cancer Research (April 8 - 13, 2022 New Orleans, LA), poster

2021

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

J Meyerhardt;Q Shi;C Fuchs;J Meyer;D Niedzwiecki;T Zemla;P Kumthekar;K Guthrie;F Couture;JP Kuebler;J Bendell;P Kumar;D Lewis;B Tan;M Bertagnolli;A Grothey;H Hochster;R Goldberg;A Venook;CD Blanke;E O'Reilly;AF Shields Journal of the American Medical Association Apr 6;325(13):1277-1286. doi: 10.1001/jama.2021.2454.

PMid: PMID33821899 | PMC number: PMC8025124

Prognostic value of tumor deposits in stage III colon cancer patients, a post hoc analysis of CALGB/SWOG 80702 phase III study

R Cohen;Q Shi;J Meyers;Z Jin;M Svrcek;C Fuchs;F Couture;P Kuebler;J Bendell;P Kumar;D Lewis;B Tan;M Bertagnolli;H Hochster;C Blanke;E O'Reilly;A Shields;J Meyerhardt J Clin Oncol 39, 2021 (suppl 3; abstr 10); ASCO GI Cancers Symposium (January 15-17, 2021, virtual), rapid abstract presentation (oral)

Combining tumor deposits with the number of lymph node metastases to improve the prognostic accuracy in stage III colon cancer: a post hoc analysis of the CALGB/SWOG 80702 phase III study (Alliance)

R Cohen;Q Shi;J Meyers;Z Jin;M Svrcek;C Fuchs;F Couture;P Kuebler;J Bendell;A De Jesus-Acosta;P Kumar;D Lewis;B Tan;M Bertagnolli;PA Philip;CD Blanke;E O'Reilly;AF Shields;J Meyerhardt Annals of Oncology, Oct;32(10):1267-1275

PMid: PMID34293461

Early-onset stage II/III colorectal adenocarcinoma in the IDEA database: Treatment adherence, toxicities, and outcomes from adjuvant fluoropyrimidine and oxaliplatin.

E Fontana;J Meyers;A Sobrero;A Iveson;AF Shields;J Taieb;T Yoshino;I Souglakos;E Smyth;F Lordick;M Moehler;A Harkin;R LaBianca;J Meyerhardt;T Andre;T Yamanaka;I Boykovinas;A Grothey;I Ben-Aharon J Clin Oncol 39, 2021 (suppl 15; abstr 3517); (ASCO 2021 Annual Meeting), poster discussion

Early-Onset Colorectal Adenocarcinoma in the IDEA database: Treatment Adherence, Toxicities and Outcomes with 3 and 6 months of Adjuvant Fluoropyrimidine and Oxaliplatin

E Fontana;J Meyers;A Sobrero;T Iveson;AF Shields;J Taieb;T Yoshino;I Souglakos;E Smyth;F Lordick;M Moehler;A Giraut;A Harkin;R Labianca;J Meyerhardt;T Andre;T Yamanaka;I Boukovinas;S Lonardi;M Saunders;D Vernerey;E Oki;V Georgoulias;I Ben-Aharon;Q Shi Journal of Clinical Oncology Dec 20;39(36):4009-4019. doi: 10.1200/JCO.21.02008. Epub 2021 Nov 9

PMid: PMID34752136 | PMC number: PMC8677996

2020

Celecoxib in addition to standard adjuvant therapy with 5-fluorouracil, leucovorin, oxaliplatin (FOLFOX) in stage III colon cancer: Results from CALGB/SWOG 80702

J Meyerhardt;Q Shi;C Fuchs;D Niedzwiecki;T Zemla;P Kumthekar;K Guthrie;F Couture;JP Kuebler;J Bendell;P Kumar;D Lewis;B Tan;M Bertagnolli;A Grothey;H Hochster;R Goldberg;A Venook;CD Blanke;AF Shields J Clin Oncol 38: 2020 (suppl; abstr 4003);American Society of Clinical Oncology Annual Meeting (5/29/2020 - 6/2/2020, Chicago, IL), oral

Overall survival (OS) and long-term disease-free survival (DFS) of three versus six months of adjuvant (adj) oxaliplatin and fluoropyrimidine-based therapy for patients (pts) with stage III colon cancer (CC): Final results from the IDEA (International Duration Evaluation of Adj chemotherapy) collaboration

A Sobrero;T Andre;J Meyerhardt;A Grothey;T Iveson;T Yoshino;I Souglakos;J Meyers;R Labianca;M Saunders;D Vernerey;T Yamanaka;I Boukovinas;E Georgoulias;V Torri;A Harkin;J Taieb;A Shields;Q Shi J Clin Oncol 38: 2020 (suppl; abstr 4004); American Society of Clinical Oncology 2020 Annual Meeting, oral

Effect of duration of adjuvant chemotherapy for patients with stage III colon cancer (IDEA collaboration): final results from a prospective, pooled analysis of six randomised, phase 3 trials

T Andre;J Meyerhardt;T Iveson;A Sobrero;T Yoshino;I Souglakos;D Niedzwiecki;M Saunders;R Labianca;T Yamanaka;I Boukovinas;D Vernerey;J Meyers;A Harkin;V Torri;E Georgoulias;E Oki;J Taieb;AF Shields;Q Shi Lancet Oncology Dec;21(12):1620-1629. doi: 10.1016/S1470-2045(20)30527-1.

PMid: PMID33271092 | PMC number: PMC7786835

2018

Duration of Adjuvant Chemotherapy for Stage III Colon Cancer

A Grothey;A Sobrero;A Shields;T Yoshino;J Paul;J Taieb;I Souglakos;Q Shi;R Kerr;R Labianca;J Meyerhardt;D Vernerey;T Yamanaka;I Boukovinas;JP Meyers;LA Renfro;D Niedzwiecki;V Torri;D Sargent;T Andre;T Iveson New England Journal of Medicine Mar 29;378(13):1177-1188

PMid: PMID29590544 | PMC number: PMC6426127

Effect of age, gender, and performance status (PS) on the duration results of adjuvant chemotherapy for stage III colon cancer: The IDEA collaboration

A Shields;FS Ou;J Paul;A Sobrero;T Yoshino;J Taieb;I Souglakos;Q Shi;R Kerr;R Labianca;T Yamanaka;D Vernerey;I Boukovinas;T Kato;V Torri;S Kakolyris;T Andre;T Grothey;J Meyerhardt;T Iveson J Clin Oncol 36, 2018 (suppl; abstr 3599); ASCO Annual Meeting (June 1- 5, 2018, Chicago, IL), poster session

The hard road to data interpretation: 3 or 6 months of adjuvant chemotherapy for patients with stage III colon cancer? [Special Article; Review]

A Sobrero;A Grothey;T Iveson;R Labianca;T Yoshino;J Taieb;T Maughan;M Buyse;T Andre;J Meyerhardt;A Shields;I Souglakos;J Douillard;A Cervantes Annals of Oncology May 1;29(5):1099-1107

PMid: PMID29438451 | PMC number: PMC6864492

2017

Prospective pooled analysis of six phase III trials investigating duration of adjuvant oxaliplatin-based therapy (3 versus 6 months) for patients with stage III colon cancer: The IDEA(International Duration Evaluation of Adjuvant chemotherapy) collaboration

Q Shi;A Sobrero;A Shields;T Yoshino;J Taieb;I Souglakos;R Kerr;R Labianca;J Meyerhardt;F Bonnetain;T Watanabe;I Mpoukovinas;L Renfro;A Grothey;D Niedzwiecki;V Torri;T Andre;D Sargent J Clin Oncol 35, 2017 (suppl; abstr LBA1); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), oral, plenary

Prospective pooled analysis of six phase III trials investigating duration of adjuvant (adj) oxaliplatin-based therapy (3 vs 6 months) for patients (pts) with stage III colon cancer (CC): The IDEA (International Duration Evaluation of Adjuvant chemotherapy) collaboration

A Grothey;AF Sobrero;JA Meyerhardt;T Yoshino;J Paul;J Taieb;I Soougklakos;R Kerr;R Labianca;A Shields;F Bonnetain;T Yamanaka;I Boukovinas;Q Shi;JP Meyers;D Niedzwiecki;V Torri;DJ Sargent;T Andre;T Iveson European Society of Medical Oncology (ESMO) 2017 (September 8-12, 2017, Madrid, Spain), poster

2014

The IDEA (International Duration Evaluation of Adjuvant Chemotherapy) collaboration: a prospective pooled analysis of > 11,500 patients from 6 Phase III trials of adjuvant therapy duration with FOLFOX (FOLFOX4 or modified FOLFOX6) or XELOX (3 versus 6 months) for stage III colon cancer

D Sargent;J Paul;A Sobrero;T Andre;A Shields;T Yoshino;I Souglakos;T Iveson;R Labianca;J Taieb;JA Meyerhardt;A Ohtsu;A Grothey Annals of Oncology 25 (Suppl 4): iv1 - mdu438.66; ESMO 2014 Congress (September 26-30, 2014, Madrid, Spain), poster presentation;