NCT01417286

Accelerated Radiation Therapy After Surgery in Treating Patients With Breast Cancer

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Rutgers, The State University of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
RADIATION	External beam radiation therapy	Hypofractionated accelerated radiation therapy over 11 days

Timeline

• Start date: 2010-12-21
• Primary completion: 2020-02-20
• Completion: 2020-02-20
• First posted: 2011-08-16
• Last updated: 2023-04-20
• Results posted: 2023-04-20

Locations

2 sites across 1 country: United States