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01-08-2013 | Pancreatic Tumors

Borderline Resectable Pancreatic Cancer: Need for Standardization and Methods for Optimal Clinical Trial Design

Authors: Matthew H. G. Katz, MD, Robert Marsh, MD, Joseph M. Herman, MD, Qian Shi, PhD, Eric Collison, MD, Alan P. Venook, MD, Hedy L. Kindler, MD, Steven R. Alberts, MD, Philip Philip, MD, Andrew M. Lowy, MD, Peter W. T. Pisters, MD, Mitchell C. Posner, MD, Jordan D. Berlin, MD, Syed A. Ahmad, MD

Published in: Annals of Surgical Oncology | Issue 8/2013

Abstract

Background

Methodological limitations of prior studies have prevented progress in the treatment of patients with borderline resectable pancreatic adenocarcinoma. Shortcomings have included an absence of staging and treatment standards and pre-existing biases with regard to the use of neoadjuvant therapy and the role of vascular resection at pancreatectomy.

Methods

In this manuscript, we review limitations of studies of borderline resectable PDAC reported to date, highlight important controversies related to this disease stage, emphasize the research infrastructure necessary for its future study, and present a recently-approved Intergroup pilot study (Alliance A021101) that will provide a foundation upon which subsequent well-designed clinical trials can be performed.

Results

We identified twenty-three studies published since 2001 which report outcomes of patients with tumors labeled as borderline resectable and who were treated with neoadjuvant therapy prior to planned pancreatectomy. These studies were heterogeneous in terms of the populations studied, the metrics used to characterize therapeutic response, and the indications used to select patients for surgery. Mechanisms used to standardize these and other issues that are incorporated into Alliance A021101 are reviewed.

Conclusions

Rigorous standards of clinical trial design incorporated into trials of other disease stages must be adopted in all future studies of borderline resectable pancreatic cancer. The Intergroup trial should serve as a paradigm for such investigations.

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Title: Borderline Resectable Pancreatic Cancer: Need for Standardization and Methods for Optimal Clinical Trial Design
Authors: Matthew H. G. Katz, MD
Robert Marsh, MD
Joseph M. Herman, MD
Qian Shi, PhD
Eric Collison, MD
Alan P. Venook, MD
Hedy L. Kindler, MD
Steven R. Alberts, MD
Philip Philip, MD
Andrew M. Lowy, MD
Peter W. T. Pisters, MD
Mitchell C. Posner, MD
Jordan D. Berlin, MD
Syed A. Ahmad, MD
Publication date: 01-08-2013
Publisher: Springer US
Published in: Annals of Surgical Oncology / Issue 8/2013
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI: https://doi.org/10.1245/s10434-013-2886-9

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Springer Medicine

Borderline Resectable Pancreatic Cancer: Need for Standardization and Methods for Optimal Clinical Trial Design

Abstract

Background

Methods

Results

Conclusions

Keynote webinar | Spotlight on sleep in brain health

Springer Medicine

Abstract

Background

Methods

Results

Conclusions

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