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
Participants
NCORP,
Members, Radiation Oncologists, Surgeons, Pathologists, ECOG, NCCTG, RTOG, CALGB, NCIC-CTG
Treatment
Leucovorin + 5-FU
Levamisole
Radiation Therapy
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.
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)
