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

Hagen F. Kennecke, Rebecca Auer, May Cho, N. Arvind Dasari, Cynthia Davies-Venn, Cathy Eng, Jennifer Dorth, Julio Garcia-Aguilar, Manju George, Karyn A. Goodman, Lillian Kreppel, Joshua E. Meyer, Jose Monzon, Leonard Saltz, Deborah Schrag, J. Joshua Smith, Jason A. Zell, Prajnan Das

Research output: Contribution to journalArticlepeer-review

2 Scopus citations

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.

Original languageEnglish
Pages (from-to)1457-1464
Number of pages8
JournalJournal of the National Cancer Institute
Volume115
Issue number12
DOIs
StatePublished - Nov 6 2023

Keywords

  • Chemoradiotherapy
  • Consensus
  • Humans
  • National Cancer Institute (U.S.)
  • Neoadjuvant Therapy
  • Rectal Neoplasms/pathology
  • United States

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