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Randomized Trial Testing the Safety and Patient Experience of Short Course Radiation after Mastectomy and Breast Reconstruction for Breast Cancer


Active: No
Cancer Type: Breast Cancer NCT ID: NCT03414970
Trial Phases: Phase III Protocol IDs: A221505 (primary)
A221505
A221505
NCI-2017-00817
Eligibility: 18 Years and older, Male and Female Study Type: Supportive care
Study Sponsor: Alliance for Clinical Trials in Oncology
NCI Full Details: http://clinicaltrials.gov/show/NCT03414970

Summary

This phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage II-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.

Objectives

PRIMARY OBJECTIVE:
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).

PHOTOGRAPHIC COSMETIC ASSESSMENT 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.

LYMPHEDEMA ASSESSMENT OBJECTIVE:
I. To estimate the incidence of arm lymphedema by treatment arm.

PATIENT REPORT OUTCOMES (PRO) OBJECTIVES:
I. 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.
II. To estimate patient satisfaction with trial participation by treatment arm as measured by the Was It Worth It Questionnaire at 24 months after radiation.

ECONOMIC ANALYSIS OBJECTIVES:
I. To compare the direct and indirect patient costs for radiation therapy by treatment arm.
II. To compare patient reported total health care service utilization 12 months after the completion of radiation.
III. To compare the economic impact of treatment.

CORRELATIVE SCIENCE OBJECTIVES:
I. 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.
II. 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 up to 15 years.

Treatment Sites in Georgia

Emory Saint Joseph's Hospital
5665 Peachtree Dunwoody Road NE
Atlanta, GA 30342
www.emoryhealthcare.org



Emory University Hospital - Midtown
550 Peachtree Street NE
Atlanta, GA 30308
404-686-4411
www.emoryhealthcare.org



Grady Memorial Hospital
80 Jesse Hill Jr. Drive, SE
Atlanta, GA 30303
www.gradyhealth.org



Piedmont Fayette Hospital
1255 Highway 54 West
Fayetteville, GA 30214
404-851-2340
www.piedmont.org



Piedmont Hospital - Atlanta
1968 Peachtree Road, NW
Atlanta, GA 30309
www.piedmont.org



Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.