NCI Rectal-Anal Task Force consensus recommendations for design of clinical trials in rectal cancer Journal Article

   


Authors: Kennecke, H. F.; Auer, R.; Cho, M.; Dasari, N. A.; Davies-Venn, C.; Eng, C.; Dorth, J.; Garcia-Aguilar, J.; George, M.; Goodman, K. A.; Kreppel, L.; Meyer, J. E.; Monzon, J.; Saltz, L.; Schrag, D.; Smith, J. J.; Zell, J. A.; Das, P.; on behalf of the National Cancer Institute Rectal-Anal Task Force
Article Title: NCI Rectal-Anal Task Force consensus recommendations for design of clinical trials in rectal cancer
Abstract: The optimal management of locally advanced rectal cancer is rapidly evolving. The National Cancer Institute Rectal-Anal Task Force convened an expert panel to develop consensus on the design of future clinical trials of patients with rectal cancer. A series of 82 questions and subquestions, which addressed radiation and neoadjuvant therapy, patient perceptions, rectal cancer populations of special interest, and unique design elements, were subject to iterative review using a Delphi analytical approach to define areas of consensus and those in which consensus is not established. The task force achieved consensus on several areas, including the following: 1) the use of total neoadjuvant therapy with long-course radiation therapy either before or after chemotherapy, as well as short-course radiation therapy followed by chemotherapy, as the control arm of clinical trials; 2) the need for greater emphasis on patient involvement in treatment choices within the context of trial design; 3) efforts to identify those patients likely, or unlikely, to benefit from nonoperative management or minimally invasive surgery; 4) investigation of the utility of circulating tumor DNA measurements for tailoring treatment and surveillance; and 5) the need for identification of appropriate end points and recognition of challenges of data management for patients who enter nonoperative management trial arms. Substantial agreement was reached on priorities affecting the design of future clinical trials in patients with locally advanced rectal cancer. © 2023 The Author(s). Published by Oxford University Press. All rights reserved.
Keywords: adult; controlled study; cancer surgery; major clinical study; review; fluorouracil; systemic therapy; united states; adjuvant therapy; neoadjuvant therapy; antineoplastic agent; quality control; consensus; quality of life; carcinoembryonic antigen; attitude to health; pathology; health care quality; patient participation; colonoscopy; delphi study; national cancer institute (u.s.); rectal neoplasms; rectum cancer; rectum tumor; patient attitude; national health organization; chemoradiotherapy; induction chemotherapy; randomized controlled trial (topic); study design; phase 2 clinical trial (topic); phase 3 clinical trial (topic); patient-reported outcome; consolidation chemotherapy; humans; human; male; circulating tumor dna; short-course radiotherapy; biosimilar agent; clinical trial protocol; cancer free survival; therapy escalation; rectal anal task force
Journal Title: JNCI: Journal of the National Cancer Institute
Volume: 115
Issue: 12
ISSN: 0027-8874
Publisher: Oxford University Press  
Date Published: 2023-12-01
Start Page: 1457
End Page: 1464
Language: English
DOI: 10.1093/jnci/djad143
PUBMED: 37535679
PROVIDER: scopus
PMCID: PMC11032701
DOI/URL:

https://www.scopus.com/inward/record.uri?eid=2-s2.0-85179131401&doi=10.1093%2fjnci%2fdjad143&partnerID=40&md5=cb45fbe3675da562dd7ae7a0f12a8da0
Notes: Source: Scopus
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  1. Deborah Schrag
    229 Schrag
  2. Julio Garcia Aguilar
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  3. Jesse Joshua Smith
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