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

Official Title

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

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 tumour cells that remain after surgery and have fewer side effects.

Trial Description

Primary Outcome:

• Rate of breast reconstruction complications

• Incidence of acute and late radiation complications based on Common Terminology Criteria for Adverse Events 4.0 toxicity
• Local and local regional recurrence
• Local and local regional recurrence-free survival
• Reconstruction complication rates based on reconstruction method (autologous +/- implant versus [vs.] implant only) and timing of reconstruction received (immediate vs. intent for delayed)
• Reconstructed breast photographic cosmetic scores
• Reconstructed breast photographic cosmetic scores based on the method and timing of reconstruction received
• Incidence of arm lymphedema as measured by percent change in ipsilateral arm volume post-radiation from its pre-radiation volume
• Physical well-being, psychosocial well-being, sexual well-being, satisfaction with breast/nipples/abdomen, and satisfaction with overall outcome
• Patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire
• Economic analyses

PRIMARY OBJECTIVES:

• 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.
• 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.

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.

View this trial on ClinicalTrials.gov