E-Newsletter - September 2021
Spotlight on Alliance Trials


The Alliance for Clinical Trials in Oncology is pleased to announce that Alliance A221505 (led by Matthew M. Poppe, MD, of University of Utah Huntsman Cancer Institute) has met its accrual goal of 880 patients and has been closed to accrual. Alliance A221505: RT CHARM: Phase III randomized trial of hypofractionated post mastectomy radiation with breast Reconstruction.

This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells that remain after surgery and have fewer side effects.

Objective: To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation.

Secondary objectives:
-- To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity.
-- To evaluate the local and local regional recurrence rate.
-- To compare reconstruction complication rates based on reconstruction method (autologous +/- implant versus [vs] implant only) and timing of reconstruction received (immediate vs. intent for delayed).

Tertiary objectives:
-- To evaluate reconstructed breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation.
-- To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation based on the method and timing of reconstruction received.
-- To estimate the incidence of arm lymphedema by treatment arm. IV. To compare physical well-being, psychosocial well-being, sexual well-being, satisfaction with breast/nipples/abdomen, and satisfaction with overall outcome between the treatment arms at 24 months after radiation.
-- To estimate patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire at 24 months after radiation.
-- To compare the direct and indirect patient costs for radiation therapy by treatment arm.
-- To compare patient-reported total health care service utilization 12 months after the completion of radiation.
-- To compare the economic impact of treatment.
-- To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 and determine correlations with a higher likelihood of adverse radiation reactions (radiation sensitivity) and with toxicities.
-- To analyze polymorphisms in MDM2 and in genes including TP53, ATM, TGFB1, IL4, IL6, and IL10 to determine correlations with secondary endpoints such as local-regional control.

Patients are followed up for five years after completion of the trial.

For more information, visit the Alliance A221505 trial page.



For other articles in this issue of the Alliance E-News newsletter, see below.