Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer

Stage IIIA Breast Cancer Clinical Trial

Official title: Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women With Breast Cancer: A Phase II Trial

Status Completed

Clinical Trial Summary

This phase II trial studies how well giving accelerated radiation therapy (RT) after surgery works in treating patients with breast cancer. RT uses high energy x rays to kill tumor cells. Giving RT after surgery may kill any remaining tumor cells

Clinical Trial Description

PRIMARY OBJECTIVES:

I. Freedom from local failure and freedom from regional failure.

SECONDARY OBJECTIVES:

I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy.

III. To correlate toxicity, cosmesis, and local control with molecular markers.

OUTLINE:

Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Carcinoma, Ductal, Breast
• Carcinoma, Lobular
• Inflammatory Breast Cancer
• Invasive Ductal Breast Carcinoma
• Invasive Lobular Breast Carcinoma
• Mucinous Ductal Breast Carcinoma
• Papillary Ductal Breast Carcinoma
• Stage II Breast Cancer
• Stage IIIA Breast Cancer
• Stage IIIB Breast Cancer
• Stage IIIC Breast Cancer
• Tubular Ductal Breast Carcinoma

• NCT number: NCT01417286
• Study type: Interventional
• Source: Rutgers, The State University of New Jersey
• Status: Completed
• Phase: Phase 2
• Start date: December 21, 2010
• Completion date: February 20, 2020