SWOG clinical trial number
SWOG-9415 (INT-0153) (CALGB-9498) (ECOG-S9415) (NCCTG-S9415)

Phase III Randomized Trial of 5-FU/Leucovorin/Levamisole versus 5-FU Continuous Infusion/Levamisole as Adjuvant Therapy for High-Risk Resectable Colon Cancer, Intergroup.

Closed
Phase
Accrual
71%
Published
Abbreviated Title
High Risk Resectable Colon
Activated
12/01/1994
Closed
12/15/1999

Research committees

Gastrointestinal Cancer

Treatment

5-Fluorouracil Leucovorin Calcium Levamisole

Publication Information Expand/Collapse

2018

Survival by Hispanic Ethnicity among Cancer Patients Participating in SWOG Clinical Trials

M Chavez-MacGregor;J Unger;A Moseley;S Ramsey;DL Hershman Cancer Apr 15;124(8):1760-1769; Jan 25 [Epub ahead of print]

PMid: PMID29370458 | PMC number: PMC5963502

Association of sex and adverse events (AEs) of adjuvant chemotherapy (ACT) in early stage colon cancer (CC): A pooled analysis of 28,636 patients (pts) in the ACCENT database

AD Wagner;A Grothey;T Andre;J Dixon;N Wolmark;D Haller;CJ Allegra;E VanCutsem;T George;A DeGramont;S Alberts;C Twelves;M O'Connell;L Saltz;C Blanke;G Francini;R Kerr;R Goldberg;G Yothers;Q Shi J Clin Oncol 36, 2018 (suppl; abstr 3603); ASCO 2018 Annual Meeting (June 1-5, 2018, Chicago, IL), poster session

The association between ASCO Value framework and scientific and clinical impact of SWOG phase III clinical trials

V Nghiem;R Vaidya;M Banegas;D Hershman;J Unger AcademyHealth Annual Research Meeting (June 23-26, 2018, Seattle, WA), poster

2017

Patterns of osteoporosis (OP) in survivors of colorectal cancer (CRC) enrolled on SWOG trials

A Barzi;D Hershman;C Till;H Lenz;H Hochster;W Barlow;J Unger J Clin Oncol 35, 2017 (suppl; abstr 10056); American Society of Clinical Oncology Annual Meeting (June 2-6, 2017, Chicago, IL), poster session

2016

Determinants of early mortality among 37,568 patients with colon cancer who participated in 25 clinical trials from the Adjuvant Colon Cancer Endpoints Database

WY Cheung;LA Renfro;D Kerr;A de Gramont;LB Saltz;A Grothey;SR Alberts;T Andre;KA Guthrie;R LaBianca;G Francini;J-F Seitz;C O'Callaghan;C Twelves;E Van Cutsem;DG Haller;G Yothers;DJ Sargent Journal of Clinical Oncology, Apr 10;34(11):1182-1189

PMid: PMID26858337 | PMC number: PMC4933130

Validity of Adjuvant! Online in older patients with stage III colon cancer based on 2967 patients from the ACCENT database

D Papamichael;LA Renfro;C Matthaiou;G Yothers;L Saltz;KA Guthrie;E Van Cutsem;H Schmoll;R Labianca;T Andre;M O'Connell;SR Alberts;DG Haller;P Kountourakis;D Sargent Journal of Geriatric Oncology 2016 Jul 25. pii: S1879-4068(16)30088-1. doi: 10.1016/j.jgo.2016.07.002 Jul 25 [Epub ahead of print]

PMid: PMID27468630 | PMC number: PMC5159186

2015

Survival following early-stage colon cancer: an ACCENT-based comparison of patients versus a matched international general population [Collaborators: K Guthrie, C Blanke] (https://www.ncbi.nlm.nih.gov/pubmed/25697217)

LA Renfro;A Grothey;D Kerr;DG Haller;T Andre;E Van Cutsem;L Saltz;R Labianca;CL Loprinzi;SR Alberts;H Schmoll;C Twelves;G Yothers;DJ Sargent Annals of Oncology May;26(5):950-958; 2015

PMid: PMID25697217 | PMC number: PMC4405281

2013

Modeling the relationship between progression-free survival and overall survival: the phase 2/3 trial

M Redman;B Goldman;M LeBlanc;A Schott;LH Baker Clinical Cancer Research, 19(10):2646-2656;

PMid: PMID23669424 | PMC number: PMC4131693

The predictive and prognostic value of sex in early-stage colon cancer: a pooled analysis of 33,345 patients from the ACCENT database

W Cheung;Q Shi;M O'Connell;J Cassidy;CD Blanke;DJ Kerr;J Meyers;E Van Cutsem;SR Alberts;G Yothers;D Sargent Clinical Colorectal Cancer 12(3):179-187

PMid: PMID23810482 | PMC number: PMC3760214

Comparison of outcomes after fluorouracil-based adjuvant therapy for stages II and III colon cancer between 1978 to 1995 and 1996 to 2007: evidence of stage migration from the ACCENT database

Q Shi;T Andre;A Grothey;G Yothers;SR Hamilton;BM Bot;DG Haller;E van Cutsem;C Twelves;J Benedetti;MJ O'Connell;DJ Sargent Journal of Clinical Oncology 31(29):3656-3663

PMid: PMID23980089 | PMC number: PMC3804289

2011

Outcomes among black patients with stage II/III colon cancer receiving adjuvant chemotherapy: an accent group analysis [PMID21997132; PMC3196480]

G Yothers;D Sargent;N Wolmark;R Goldberg;M O'Connell;J Benedetti;L Saltz;J Dignam;A Blackstock Journal of the National Cancer Institute 103(20):1498-1506; JAMA

2010

Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon cancer: simulations based on the 20,800 patient ACCENT data set [PMC2815708; PMID20008641]

A de Gramont;J Hubbard;Q Shi;M O'Connell;M Buyse;J Benedetti;B Bott;C O'Callaghan;G Yothers;RM Goldberg;CD Blanke;A Benson;Q Deng;S Alberts;T Andre;N Wolmark;A Grothey;D Sargent Journal of Clinical Oncology 28(3):460-465

Outcomes following adjuvant treatment (AT) for colon cancer (CC) 1978-1995 versus 1996-2007: impact on recurrence rate, time from recurrence to death (TRD), and overall survival (OS) - findings from the ACCENT dataset

T Andre;Q Shi;G Yothers;BM Bott;G Haller;E Van Cutsem;J Cassidy;J Benedetti;M O'Connell;DJ Sargent Journal of Clinical Oncology 28:15s (suppl; abstr 3616); ASCO Annual Meeting; poster

Obesity is an independent prognostic variable in colon cancer survivors [PMID20215553; PMC2948494]

F Sinicrope;NR Foster;DJ Sargent;MJ O'Connell;C Rankin Clinical Cancer Research 16(6):1884-1893

2008

Survival following recurrence in stage II and III colon cancer: findings from the ACCENT data set [PMID:18467725]

MJ O'Connell;ME Campbell;R Goldberg;A Grothey;J Seitz;JK Benedetti;T Andre;DG Haller;DJ Sargent Journal of Clinical Oncology 26(14):2336-2341

2007

End points for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the Accent group [PMID17876008]

DJ Sargent;S Patiyil;G Yothers;DG Haller;R Gray;J Benedetti;M Buyse;R Labianca;JF Seitz;C O'Callaghan;G Francini;A Grothey;M O'Connell;PJ Catalano;D Kerr;E Green;HS Wieand;RM Goldberg;de Gramont Journal of Clinical Oncology 25(29):4569-4574

2005

Phase III Southwest Oncology Group 9415/ Intergroup 0153 randomized trial of fluorouracil, leucovorin, and levamisole versus fluorouracil continuous infusion and levamisole for adjuvant treatment of stage III and high-risk stage II colon cancer

EA Poplin;JK Benedetti;NC Estes;DG Haller;RJ Mayer;RM Goldberg;GR Weiss;SE Rivkin;JS Macdonald Journal of Clinical Oncology 23(9):1819-1825

2000

Phase III randomized trial of bolus 5-FU/leucovorin/levamisole versus 5-FU continuous infusion/levamisole as adjuvant therapy for high risk colon cancer (SWOG 9415/INT-0153)

E Poplin;J Benedetti;N Estes;D Haller;R Mayer;R Goldberg;J Macdonald Proc of the American Society of Clinical Oncology 19:240a(#931)

Other Clinical Trials

SWOG Clinical Trial Number
S9304A-ICSC

Investigation of Thioredoxin-1 Family Protein Expression in Rectal Cancer

Research Committee(s)
Gastrointestinal Cancer
Closed
SWOG Clinical Trial Number
SWOG-8037

Combined Therapies for Squamous Cell Carcinoma of the Esophagus

Research Committee(s)
Gastrointestinal Cancer
Activated
02/16/1981
Closed
01/19/1984
Closed
Phase
II
Published
SWOG Clinical Trial Number
SWOG-8591(NCI Intergroup #0035)

An Evaluation of Levamisole Alone or Levamisole plus 5-Fluorouracil as Surgical Adjuvant Treatment for Resectable Adenocarcinoma of the Colon

Research Committee(s)
Gastrointestinal Cancer
Activated
01/14/1985
Closed
10/01/1987
Closed
Phase
Published