Challenges and opportunities for early phase clinical trials of novel drug–radiotherapy combinations: recommendations from NRG Oncology, the American Society for Radiation Oncology (ASTRO), the American College of Radiology (ACR), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (ACRO)

Zachary S Zumsteg; Siddharth Sheth; Salma K Jabbour; Krishnan R Patel; Randall J Kimple; Terence M Williams; Meng Xu-Welliver; Pedro A Torres-Saavedra; Arta M Monjazeb; Jyoti Mayadev; Steven E Finkelstein; John M Buatti; Sandip P Patel; Steven H Lin

doi:10.1016/S1470-2045(24)00264-X

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Challenges and opportunities for early phase clinical trials of novel drug–radiotherapy combinations: recommendations from NRG Oncology, the American Society for Radiation Oncology (ASTRO), the American College of Radiology (ACR), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (ACRO)

Journal article

Peer reviewed

Challenges and opportunities for early phase clinical trials of novel drug–radiotherapy combinations: recommendations from NRG Oncology, the American Society for Radiation Oncology (ASTRO), the American College of Radiology (ACR), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (ACRO)

Zachary S Zumsteg, Siddharth Sheth, Salma K Jabbour, Krishnan R Patel, Randall J Kimple, Terence M Williams, Meng Xu-Welliver, Pedro A Torres-Saavedra, Arta M Monjazeb, Jyoti Mayadev, …

The lancet oncology, Vol.25(10), pp.e489-e500

10/2024

DOI: 10.1016/S1470-2045(24)00264-X

PMCID: PMC11778933

PMID: 39362260

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Abstract

NRG Oncology's Developmental Therapeutics and Radiation Therapy Subcommittee assembled an interdisciplinary group of investigators to address barriers to successful early phase clinical trials of novel combination therapies involving radiation. This Policy Review elucidates some of the many challenges associated with study design for early phase trials combining radiotherapy with novel systemic agents, which are distinct from drug–drug combination development and are often overlooked. We also advocate for potential solutions that could mitigate or eliminate some of these barriers, providing examples of specific clinical trial designs that could help facilitate efficient and effective evaluation of novel drug–radiotherapy combinations.

Details

Title: Subtitle: Challenges and opportunities for early phase clinical trials of novel drug–radiotherapy combinations: recommendations from NRG Oncology, the American Society for Radiation Oncology (ASTRO), the American College of Radiology (ACR), the Sarah Cannon Research Institute, and the American College of Radiation Oncology (ACRO)
Creators: Zachary S Zumsteg - Cedars-Sinai Medical Center
Siddharth Sheth - University of North Carolina at Chapel Hill
Salma K Jabbour - Rutgers, The State University of New Jersey
Krishnan R Patel - National Cancer Institute
Randall J Kimple - University of Wisconsin–Madison
Terence M Williams - City Of Hope National Medical Center
Meng Xu-Welliver - Mayo Clinic
Pedro A Torres-Saavedra - National Institutes of Health
Arta M Monjazeb - University of California San Diego
Jyoti Mayadev - University of California San Diego
Steven E Finkelstein - Sarah Cannon
John M Buatti - University of Iowa
Sandip P Patel - University of California San Diego Medical Center
Steven H Lin - The University of Texas MD Anderson Cancer Center
Resource Type: Journal article
Publication Details: The lancet oncology, Vol.25(10), pp.e489-e500
DOI: 10.1016/S1470-2045(24)00264-X
PMID: 39362260
PMCID: PMC11778933
NLM abbreviation: Lancet Oncol
ISSN: 1470-2045
eISSN: 1474-5488
Publisher: Elsevier Ltd; NEW YORK
Language: English
Date published: 10/2024
Academic Unit: Radiation Oncology; Neurosurgery; Otolaryngology
Record Identifier: 9984721135602771

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