NCT01245712

Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer

Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Detailed description

PRIMARY OBJECTIVES: I. To assess the cosmesis, acute toxicity and late toxicity in patients treated with accelerated partial breast irradiation delivered with proton radiation. SECONDARY OBJECTIVES: I. To evaluate the convenience of accelerated partial breast irradiation and quality of life during accelerated partial breast irradiation. II. To estimate the in-breast tumor control rates in patients treated with accelerated partial breast irradiation delivered with proton radiation. III. Compare dosimetry to alternate treatment modalities. OUTLINE: Within 10 weeks of last breast cancer surgery, patients undergo accelerated partial breast irradiation (APBI) delivered with proton radiation twice daily (BID) for 5 days. After completion of study treatment, patients are followed up at 6 weeks, 6 months, 1 year, and 18 months, then annually for 10 years.

Conditions

• Breast Adenocarcinoma
• Ductal Breast Carcinoma In Situ
• Invasive Breast Carcinoma
• Stage 0 Breast Cancer AJCC v6 and v7
• Stage I Breast Cancer AJCC v7
• Stage IA Breast Cancer AJCC v7
• Stage IB Breast Cancer AJCC v7
• Stage II Breast Cancer AJCC v6 and v7
• Stage IIA Breast Cancer AJCC v6 and v7
• Stage IIB Breast Cancer AJCC v6 and v7

Interventions

Type	Name	Description
RADIATION	Accelerated Partial Breast Irradiation	Undergo APBI delivered with proton radiation
RADIATION	Proton Beam Radiation Therapy	Undergo APBI delivered with proton radiation
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2010-11-15
• Primary completion: 2032-12-31
• Completion: 2032-12-31
• First posted: 2010-11-22
• Last updated: 2025-12-17

Locations

1 site across 1 country: United States