Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 100
Summary
- 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
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
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 a...
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.
Tracking Information
- NCT #
- NCT01245712
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Eric A Strom M.D. Anderson Cancer Center