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dc.contributor.authorTang, Monica
dc.contributor.authorChen, Julia
dc.contributor.authorGoldstein, David
dc.contributor.authorLinks, Matthew
dc.contributor.authorLord, Sarah
dc.contributor.authorMarschner, Ian
dc.contributor.authorSimes, Robert J
dc.contributor.authorLee, Chee K
dc.description.abstractObjectives: We evaluated how well phase II trials in locally advanced and metastatic pancreatic cancer (LAMPC) meet current recommendations for trial design. Methods: We conducted a systematic review of phase II first-line treatment trial for LAMPC. We assessed baseline characteristics, type of comparison, and primary end point to examine adherence to the National Cancer Institute recommendations for trial design. Results: We identified 148 studies (180 treatment arms, 7505 participants). Forty-seven (32%) studies adhered to none of the 5 evaluated National Cancer Institute recommendations, 62 (42%) followed 1, 31 (21%) followed 2, and 8 (5%) followed 3 recommendations. Studies varied with respect to the proportion of patients with good performance status (range, 0%-80%) and locally advanced disease (range, 14%-100%). Eighty-two (55%) studies concluded that investigational agents should progress to phase III testing; of these, 24 (16%) had documented phase III trials. Three (8%) phase III trials demonstrated clinically meaningful improvements for investigational agents. One of 38 phase II trials that investigated biological investigational agents was enriched for a biomarker. Conclusions: Phase II trials do not conform well to current recommendations for trial design in LAMPC.
dc.publisherLippincott Williams & Wilkins
dc.subject.fieldofresearchClinical Sciences
dc.subject.keywordsScience & Technology
dc.subject.keywordsLife Sciences & Biomedicine
dc.subject.keywordsGastroenterology & Hepatology
dc.subject.keywordspancreatic neoplasms
dc.subject.keywordsclinical trial design
dc.titleEvaluation of Phase II Trial Design in Advanced Pancreatic Cancer
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationTang, M; Chen, J; Goldstein, D; Links, M; Lord, S; Marschner, I; Simes, RJ; Lee, CK, Evaluation of Phase II Trial Design in Advanced Pancreatic Cancer, Pancreas, 2019, 48 (10), pp. 1274-1284
gro.hasfulltextNo Full Text
gro.griffith.authorLinks, Matthew J.

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