TY - JOUR
T1 - NCI Rectal-Anal Task Force consensus recommendations for design of clinical trials in rectal cancer
AU - Kennecke, Hagen F.
AU - Auer, Rebecca
AU - Cho, May
AU - Dasari, N. Arvind
AU - Davies-Venn, Cynthia
AU - Eng, Cathy
AU - Dorth, Jennifer
AU - Garcia-Aguilar, Julio
AU - George, Manju
AU - Goodman, Karyn A.
AU - Kreppel, Lillian
AU - Meyer, Joshua E.
AU - Monzon, Jose
AU - Saltz, Leonard
AU - Schrag, Deborah
AU - Joshua Smith, J.
AU - Zell, Jason A.
AU - Das, Prajnan
N1 - Publisher Copyright:
© 2023 The Author(s). Published by Oxford University Press. All rights reserved.
PY - 2023/12/1
Y1 - 2023/12/1
N2 - 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.
AB - 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.
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U2 - 10.1093/jnci/djad143
DO - 10.1093/jnci/djad143
M3 - Review article
C2 - 37535679
AN - SCOPUS:85179131401
SN - 0027-8874
VL - 115
SP - 1457
EP - 1464
JO - Journal of the National Cancer Institute
JF - Journal of the National Cancer Institute
IS - 12
ER -