SWOG clinical trial number
R9704
A Phase III Study of Pre and Post Chemoradiation 5-FU vs. Pre and Post Chemoradiation Gemcitabine for Postoperative Adjuvant Treatment of Resected Pancreatic Adenocarcinoma
Abbreviated Title
PANCREAS
Treatment
5-Fluorouracil
Gemcitabine hydrochloride
Pt must have histologic proof of Stage T1-4, N0-1 pancreatic adenocarcinoma and have undergone a potentially curative resection. Maximum diameter/dimension of the primary tumor as obtained from the pathologic specimen is req'd at registration as well as the tumor status at the surgical margin. Red cell phenotype for Lewis A and Lewis B antigens must be done and if positive, blood must be drawn for CA19-9 testing. Protocol tx must begin w/in 3-8 wks of surgery and w/in 5 business days of randomization. Pt must be >= 18. Pt must have Karnofsky PS of >=60. Pt should be able to maintain adequate oral nutrition and be free of significant nausea and vomiting. Pt must sign informed consent which includes a section on the possibility of the need for deep line access. Pt must have WBC >= 3000, PLT >= 100,000, bili & creatinine <= 1.5 times IULN and SGOT <= 5 times IULN.
2012
Predictive markers of gemcitabine treatment response in pancreas cancer: a pharmacogenomic pathyway approach
J Farrell;J Wong;J Moughan;W Regine;P Schaefer;A Benson;J Macdonald;X Liu;Y Yen;R Lai;Z Zheng;G Bepler;H Elsaleh Gastroenterology Vol. 142, Issue 5, Supplement 1, page S-113; Digestive Disease Week Annual Meeting, oral presentation, plenary session);
2011
The influence of total nodes examined, number of positive nodes, and lymph node ratio on survival after surgical resection and adjuvant chemoradiation for pancreatic cancer: a secondary analysis of RTOG 9704 [PMID20934270; PMC3038247]
TN Showalter;KA Winter;AC Berger;WF Regine;RA Abrams;H Safran;JP Hoffman;AB Benson;JS Macdonald;CG Willett International Journal of Radiation Oncology Biology Physics 81(5):1328-1335
Fluorouracil-based chemoradiation with either gemcitabine or fluorouracil chemotherapy after resection of pancreatic adenocarcinoma: 5-year analysis of the U.S. Intergroup/RTOG 9704 phase III trials [PMID21499862]
W Regine;KA Winter;R Abrams;H Safran;JP Hoffman;A Konski;A Benson;J Macdonald;TA Rich;CG Willett Annals of Surgical Oncology 18(5):1319-1326
2009
Human equilibrative nucleoside transporter 1 levels predict response to gemcitabine in patients with pancreatic cancer [PMID18992248]
JJ Farrell;H Elsaleh;M Garcia;R Lai;A Ammar;WF Regine;R Abrams;A Benson;J Macdonald;CE Cass;AP Dicker;JR Mackey Gastroenterology 136(1):187-195
2008
Postresection CA 19-9 predicts overall survival in patients with pancreatic cancer treated with adjuvant chemoradiation: a prospective validation by RTOG 9704 [PMID19029412; PMC2645109]
AC Berger;M Garcia;JP Hoffman;WF Regine;RA Abrams;H Safran;A Konski;A Benson;J Macdonald;CG Willett Journal of Clinical Oncology 26(36):5918-5922
2007
Correlation of RTOG 9704 (adjuvant therapy (rx) of pancreatic adenocarcinoma (pan ca)) radiation therapy quality assurance scores (RTQASc) with survival (S)
RA Abrams;KA Winter;WF Regine;H Safran;JP Hoffman;AA Konski;AB Benson;JS Macdonald;TA Rich;CG Willett Proc of the American Society of Clinical Oncology, Journal of Clinical Oncology 25(18S):#4523
2006
Rtog 9704 a phase III study of adjuvant pre and post chemoradiation (CRT) 5-fu vs. gemcitabine (G) for resected pancreatic adenocarcinoma
WF Regine;KW Winter;R Abrams;H Safran;JP Hoffman;A Konski;AB Benson;JS Macdonald;CG Willett;TA Rich Proc of the ASCO, Journal of Clinical Oncology 24(18S):#4007
Markers of folate metabolism in pancreatic cancer: thymidylate synthase, thymidine phosphorylase, and MTHFR. results from the RTOG 9704 prospective randomized adjuvant treatment trial
JJ Farrell;K Winter;M Van Rijnsoever;W Regine;R Abrams;H Safran;J Macdonald;AB Benson;C Willett;H Elsaleh ASCO 2006 Gastrointestinal Cancers Symposium #144
