Radiation Oncology/RTOG Trials/9704

RTOG 97-04 (PANCREAS)

RTOG Pancreas Trials

• Title: 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
• Objectives:
  • 1) To determine whether 5-FU based chemoradiation preceded and followed by gemcitabine improves the overall survival, local-regional and distant disease control, and/or disease-free survival as compared to 5-FU based chemoradiation preceded and followed by 5-FU in the postoperative adjuvant treatment of pancreatic carcinoma.
  • 2) To compare the acute and late toxicities between 5-FU chemoradiation preceded and followed by gemcitabine and 5-FU chemoradiation preceded and followed by 5-FU.
  • 3) To prospectively evaluate the ability of post-resectional CA19-9 to predict survival among adjuvantly treated patients who have undergone a potentially curative resection for adenocarcinoma of the pancreas.
• Protocol:

• Conclusion:
  • 2008 PMID 18319412 Fluorouracil vs gemcitabine chemotherapy before and after fluorouracil-based chemoradiation following resection of pancreatic adenocarcinoma: a randomized controlled trial. (Regine WF, JAMA. 2008) Conclusion: The addition of gemcitabine to adjuvant fluorouracil-based chemoradiation was associated with a survival benefit for patients with resected pancreatic cancer, although this improvement was not statistically significant.

• Publications:
  • 2009 Correlation of cytidine deaminase single nucleotide polymorphism and toxicity from gemcitabine in patients with pancreatic cancer from RTOG 9704. (Farrell J, [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-115, 2009.)
  • 2009 PMID 18992248 Human equilibrative nucleoside transporter 1 levels predict response to gemcitabine in patients with pancreatic cancer. (Farrell JJ, Gastroenterology. 2009)
  • 2009 Single institutional experience with oral capecitabine (Cap) in adjuvant therapy for pancreatic cancer: Gemcitabine (G) followed by Cap/RT followed by G (Piperdi B, [Abstract] American Society of Clinical Oncology 2009 Gastrointestinal Cancers Symposium, 15-17 January 2009, San Francisco, CA. A-229, 2009.)
  • 2008 PMID 19029412 Postresection CA 19-9 predicts overall survival in patients with pancreatic cancer treated with adjuvant chemoradiation: a prospective validation by RTOG 9704. (Berger AC, J Clin Oncol. 2008) Conclusion: To our knowledge, this is the first phase III trial to perform prospective analysis of CA 19-9 levels in patients treated with adjuvant chemoradiotherapy. It definitively confirms the prognostic importance of postresectional CA 19-9 levels after surgery with curative intent in patients with pancreatic cancer.
  • 2006 Abstract RTOG 9704: radiotherapy quality assurance (QA) review and survival. (Abrams RA, [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-39, S22, 2006.) Conclusion: This is the first phase III adjuvant pancreatic cancer trial to require XRT QA review. In this study Pts whose XRT did not adhere to protocol specified XRT parameters experienced inferior S. These results suggest that in this context failure to adhere to XRT protocol guidelines compromises S. NPI and S did not correlate in this study. XRT QA compliance appears to be an important parameter in adjuvant pancreatic cancer trials and should be regarded as such for future trials.