NCT03414970

Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer

RT CHARM: Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation With Breast Reconstruction

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 898 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate whether the reconstruction complication rate at 24 months post radiation is non-inferior with hypofractionation. SECONDARY OBJECTIVES: I. To evaluate the incidence of acute and late radiation complications, based on Common Terminology Criteria for Adverse Events (CTCAE) 4.0 toxicity. II. To evaluate the local and local regional recurrence rate. III. 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: I. To evaluate reconstructed breast photographic cosmetic scores with hypofractionated radiation compared to standard fractionation 24 months after radiation. II. To evaluate reconstructed breast photographic cosmetic scores 24 months after radiation based on the method and timing of reconstruction received. III. 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. V. To estimate patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire at 24 months after radiation. VI. To compare the direct and indirect patient costs for radiation therapy by treatment arm. VII. To compare patient reported total health care service utilization 12 months after the completion of radiation. VIII. To compare the economic impact of treatment. IX. 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. X. 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. OUTLINE: Patients are randomized to 1 of 2 groups. GROUP I: Patients undergo radiation therapy daily on Monday-Friday for 5-6 weeks. GROUP II: Patients undergo hypofractionated radiation therapy daily on Monday-Friday for 3-4 weeks. After completion of study, patients are followed up for 5 years.

Conditions

• Ductal Breast Carcinoma
• Invasive Breast Carcinoma
• Lobular Breast Carcinoma
• Medullary Breast Carcinoma
• Stage II Breast Cancer
• Stage IIA Breast Cancer
• Stage IIB Breast Cancer
• Stage IIIA Breast Cancer
• Tubular Breast Carcinoma

Interventions

Type	Name	Description
RADIATION	Radiation Therapy	Undergo RT
OTHER	Questionnaire Administration	Ancillary studies
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Laboratory Biomarker Analysis	Correlative studies
RADIATION	Hypofractionated Radiation Therapy	Undergo hypofractionated RT

Timeline

• Start date: 2018-03-12
• Primary completion: 2024-02-01
• Completion: 2035-08-01
• First posted: 2018-01-30
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

859 sites across 2 countries: United States, Canada