Originally published as JCO Early Release 10.1200/JCO.2009.21.9022 on October 26 2009

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Consensus Report of the National Cancer Institute Clinical Trials Planning Meeting on Pancreas Cancer Treatment

From the Karmanos Cancer Institute, Wayne State University, Detroit, MI; National Cancer Institute, National Institutes of Health, Bethesda, MD; University of Colorado, Denver, CO; Princess Margaret Hospital, Toronto, Canada; Fox Chase Cancer Center, Philadelphia, PA; Johns Hopkins Hospital, Baltimore, MD; Memorial Sloan-Kettering Cancer Center, New York, NY; Norris Cotton Cancer Center, Lebanon, NH; M. D. Anderson Cancer Center, Houston, TX; Statistical Center, Southwest Oncology Group, Seattle; Fred Hutchinson Cancer Research Center, Seattle, WA; Pfizer Oncology, New York, NY; University of California San Diego, San Diego; University of California San Francisco Medical Center, San Francisco, CA; Duke University Medical Center, Durham; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; and University of Michigan, Ann Arbor, MI.

Corresponding author: Philip A. Philip, MD, PhD, FRCP, Karmanos Cancer Institute, 4 Hudson-Weber Cancer Research Center, 4100 John R St, Detroit, MI 48201; e-mail: philipp{at}karmanos.org.

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.

See accompanying editorial on page 5487 and articles on pages 5499, 5506, and 5513

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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				J. Tabernero and T. Macarulla Changing the Paradigm in Conducting Randomized Clinical Studies in Advanced Pancreatic Cancer: An Opportunity for Better Clinical Development J. Clin. Oncol., November 20, 2009; 27(33): 5487 - 5491. [Full Text] [PDF]