Consensus report of the national cancer institute clinical trials planning meeting on pancreas cancer treatment.

Journal Article (Journal Article;Review)

Pancreatic ductal adenocarcinoma (PDAC) is the fourth leading cause of cancer mortality, despite significant improvements in diagnostic imaging and operative mortality rates. The 5-year survival rate remains less than 5% because of microscopic or gross metastatic disease at time of diagnosis. The Clinical Trials Planning Meeting in pancreatic cancer was convened by the National Cancer Institute's Gastrointestinal Cancer Steering Committee to discuss the integration of basic and clinical knowledge in the design of clinical trials in PDAC. Major emphasis was placed on the enhancement of research to identify and validate the relevant targets and molecular pathways in PDAC, cancer stem cells, and the microenvironment. Emphasis was also placed on developing rational combinations of targeted agents and the development of predictive biomarkers to assist selection of patient subsets. The development of preclinical tumor models that are better predictive of human PDAC must be supported with wider availability to the research community. Phase III clinical trials should be implemented only if there is a meaningful clinical signal of efficacy and safety in the phase II setting. The emphasis must therefore be on performing well-designed phase II studies with uniform sets of basic entry and evaluation criteria with survival as a primary endpoint. Patients with either metastatic or locally advanced PDAC must be studied separately.

Full Text

Duke Authors

Cited Authors

  • Philip, PA; Mooney, M; Jaffe, D; Eckhardt, G; Moore, M; Meropol, N; Emens, L; O'Reilly, E; Korc, M; Ellis, L; Benedetti, J; Rothenberg, M; Willett, C; Tempero, M; Lowy, A; Abbruzzese, J; Simeone, D; Hingorani, S; Berlin, J; Tepper, J

Published Date

  • November 20, 2009

Published In

Volume / Issue

  • 27 / 33

Start / End Page

  • 5660 - 5669

PubMed ID

  • 19858397

Pubmed Central ID

  • PMC7587401

Electronic International Standard Serial Number (EISSN)

  • 1527-7755

Digital Object Identifier (DOI)

  • 10.1200/JCO.2009.21.9022


  • eng

Conference Location

  • United States