SWOG clinical trial number
SWOG-9304 (INT-0144)

Postoperative Evaluation of 5-FU by Bolus Injection versus 5-FU by Prolonged Venous Infusion Prior to and Following Combined Prolonged Venous Infusion Plus Pelvic XRT Versus Bolus 5-FU Plus Leucovorin Plus Levamisole Prior to and Following Combined Pelvic XRT in Patients with Rectal Cancer, Phase III, Intergroup

Closed
Phase
Accrual
98%
Published
Abbreviated Title
RECTAL
Activated
03/01/1994
Closed
08/01/2000
Participants
NCORP, Members, Radiation Oncologists, Surgeons, Pathologists, ECOG, NCCTG, RTOG, CALGB, NCIC-CTG

Research committees

Gastrointestinal Cancer

Treatment

Leucovorin + 5-FU Levamisole Radiation Therapy

Eligibility Criteria Expand/Collapse

No prev hist of rectal ca, prev hist of colorectal ca allowed (see protocol) histologic confirmation of adenocarcinoma of the rectum, not of colonic origin; no dist mets; potentially curative resection w/ no evidence of dz; stage B2, B3 or C; no prior chemo, immuno or RT; no concomitant antineoplastic therapy.

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

Survival by Hispanic Ethnicity Among Cancer Patients participating in SWOG Clinical Trials

A Moseley;M Chavez-MacGregor;J Unger;S Ramsey;D Hershman Society for Clinical Trials Annual Meeting (May 20-23 2018, Portland, OR), oral presentation

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

2015

Pharmacogenetic analysis of INT 0144 trial: association of polymorphisms with survival and toxicity in rectal cancer patients treated with 5-FU and radiation

P Bohanes;C Rankin;H Lenz;T Winder;C Ulrich;S Smalley;K Danenberg;K Makar;W Zhang;J Benedetti;C Blanke Clinical Cancer Research Apr 1;21(7):1583-1590

PMid: PMID25589620 | PMC number: PMC4566931

2014

Polymorphisms in folate-metabolizing enzymes and response to 5-fluorouracil among stage II or III rectal cancer patients (INT-0144; SWOG 9304)

CM Ulrich;C Rankin;AT Toriola;KW Makar;O Altug-Teber;J Benedetti;RS Holmes;SR Smalley;CD Blanke;HJ Lenz Cancer 120(21):3329-3337;

PMid: PMID25041994 | PMC number: PMC4259283

2011

The final results of the SWOG S9304 phase III intergroup trial's pharmacogenetic analysis: association of polymorphisms with survival and toxicity in stage II/III rectal cancer patients treated with 5-fluorouracil (5-FU) and pelvic radiation (RT)

PMD Wilson;PO Bohanes;C Rankin;J Benedetti;CM Ulrich;S Smalley;K Makar;W Zhang;T Winder;Y Ning;A Gerger;L Benhaim;R El-Khoueiry;M Labonte;CD Blanke;HJ Lenz Journal of Clinical Oncology 29:(suppl;abstr 3542); American Society of Clinical Oncology Annual Meeting, general poster;

2010

Association of intratumoral gene expression levels of TP (thymidine phosphorylase) and VEGF are associated with clinical outcome in stage II/III rectal cancer patients treated with 5-fluorouracil (5-FU) and pelvic radiation in a phase III intergroup trial (SWOG 9304)

R Ladner;C Ulrich;C Rankin;K Danenberg;P Danenberg;SR Smalley;KW Makar;J Benedetti;CD Blanke;HJ Lenz Journal of Clinical Oncology 28:7s, 2010 (suppl; abstr 3640); ASCO Annual Meeting; poster

2008

Pelvic failure (PF) analysis in INT0144: evaluation of chemotherapy regimen, risk group stratification, and nodal count

SR Smalley;C Rankin;J Benedetti;SK Williamson;JM Robertson;R Tyvin;JA Martenson;AB Benson;RJ Mayer;C Cripps International Journal of Radiation Oncology Biology Physics 72:S70

An update of pharmacogenetic analysis of adjuvant rectal cancer patients treated with 5-Fluorouracil and pelvic radiation in a phase III intergroup trial (INT-0144, SWOG 9304)

W Zhang;C Rankin;KD Danenberg;JK Benedetti;PV Danenberg;CM Ulrich;RS Holmes;KW Makar;CD Blanke;SR Smalley;HJ Lenz Journal of Clinical Oncology 26(15S):206s, #4115

Polymorphisms in folate-metabolizing enzymes and response to 5-fluorouracil among stage II or III rectal cancer pataients (SWOG 9304)

RS Holmes;C Rankin;KW Makar;JK Benedetti;SR Smalley;CD Blanke;HJ Lenz;CM Ulrich Proceedings of the American Association for Cancer Research, abst. 4797

Pharmacogenetic analysis of stage II/III rectal cancer patients treated with 5-fluorouracil and pelvic radiation in a phase III intergroup trial (INT-0144, SWOG 9304)

W Zhang;C Rankin;F Nagashima;CM Ulrich;RS Holmes;KW Makar;JK Benedetti;CD Blanke;SR Smalley;HJ Lenz American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, abst. 300

Polymorphisms in folate-metabolizing enzymes and response to 5-fluorouracil among stage II or III rectal cancer patients (SWOG 9304)

CM Ulrich;C Rankin;RS Holmes;KW Makar;JK Benedetti;SR Smalley;CD Blanke;HJ Lenz American Society of Clinical Oncology 2008 Gastrointestinal Cancers Symposium, abst. 309, p. 223

2006

Phase III trial of fluorouracil-based chemotherapy regimens plus radiotherapy in postoperative adjuvant rectal cancer: GI INT 0144

SR Smalley;JK Benedetti;SK Williamson;JM Robertson;NC Estes;T Maher;B Fisher;TA Rich;JA Martenson;JW Kugler;AB Bennson III;DG Haller;RJ Mayer;JN Atkins;C Cripps;J Pederson;PO Periman;MS Tanaka Jr;CG Leichman;JS Macdonald Journal of Clinical Oncology 24(22):3542-3547

2003

Intergroup 0144 - phase III trial of 5-FU based chemotherapy regimens plus radiotherapy (XRT) in postoperative adjuvant rectal cancer. Bolus 5-FU vs prolonged venous infusion (PVI) before and after XRT + PVI vs bolus 5-FU + leucovorin (LV) + levamisole (LEV) before and after XRT + bolus 5-FU + LV.

SR Smalley;J Benedetti;S Williamson;J Robertson;B Fisher;J Martenson;AB Benson;M Robert;C Cripps;J Macdonald Proc of the American Society of Clinical Oncology 22:251(#1006)

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