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

  • STATUS
    Recruiting
  • End date
    Aug 27, 2035
  • participants needed
    880
  • sponsor
    Alliance for Clinical Trials in Oncology
Updated on 22 August 2021
Investigator
Matthew Poppe, MD
Primary Contact
Condell Memorial Hospital (7.3 mi away) Contact
+911 other location
diabetes
cancer
hysterectomy
beta-human chorionic gonadotropin
carcinoma
non-melanoma skin cancer
oophorectomy
human chorionic gonadotropin
tumor cells
carcinoma in situ
lobular carcinoma
hemoglobin a1c
beta human chorionic gonadotropin
skin carcinoma
invasive breast cancer
mastectomy
ductal carcinoma in situ
lobular carcinoma in situ
invasive carcinoma

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.

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.

Details
Condition Invasive Ductal Breast Carcinoma, Lobular carcinoma, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Invasive Breast Carcinoma, Invasive Breast Cancer, Medullary Breast Carcinoma, Tubular Breast Carcinoma, ductal adenocarcinoma, breast ductal carcinoma
Treatment radiation therapy, laboratory biomarker analysis, questionnaire administration, quality-of-life assessment, hypofractionated radiation therapy
Clinical Study IdentifierNCT03414970
SponsorAlliance for Clinical Trials in Oncology
Last Modified on22 August 2021

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