Radiation Therapy in Treating Women With Early Stage Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Radiation: External beam boostRadiation: whole breast irradiation
- Registration Number
- NCT00909909
- Lead Sponsor
- Rutgers, The State University of New Jersey
- Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. Giving it after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of radiation therapy and to see how well it works in treating women with early stage breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* To determine the freedom from local and regional failure in women with early stage breast cancer treated with accelerated, hypofractionated radiotherapy.
* To determine the acute and late toxicity of accelerated, hypofractionated radiotherapy using previously published toxicity scales.
Secondary
* To measure cosmesis using the Harvard cosmesis scale in patients who have undergone lumpectomy.
* To identify co-variates responsible for poor cosmetic outcome in these patients.
OUTLINE: Patients who have undergone lumpectomy undergo either intracavitary balloon brachytherapy boost and hypofractionated, accelerated whole breast irradiation (AWBI) OR 3D-conformal radiotherapy (3D-CRT)/intensity-modulated radiotherapy (IMRT) boost and AWBI. Patients who have undergone mastectomy undergo hypofractionated, accelerated chest wall irradiation.
* Intracavitary balloon brachytherapy boost and AWBI (post-lumpectomy): Patients undergo intracavitary balloon brachytherapy boost twice daily for 2 days (total of 4 fractions). Beginning 5-21 days after completion of brachytherapy, patients undergo AWBI once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
* 3D-CRT/IMRT boost and AWBI (post-lumpectomy): Patients undergo 3D-CRT/IMRT boost twice daily for 2 days (total of 4 fractions). Patients also undergo AWBI as above before or after boost radiotherapy.
* Accelerated chest wall irradiation (post-mastectomy): Patients undergo accelerated chest wall irradiation once daily 5 days a week for approximately 2 weeks (total of 11 fractions).
Patients who have undergone lumpectomy undergo frontal digital photography of the breasts at baseline, immediately before the initiation of radiotherapy, and then annually for 3 years after completion of radiotherapy. These patients also complete the Breast Cancer Treatment Outcome Scale at baseline and at 3 years after completion of radiotherapy. Physicians complete the Harvard Cosmesis scale at baseline and at 1 and 3 years after completion of radiotherapy.
After completion of study treatment, patients are followed up at weeks 1, 4, and 8 and then every 4 months for 2 years, every 6 months for 3 years, and annually thereafter.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description B whole breast irradiation Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost A whole breast irradiation 3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI) B External beam boost Accelerated whole breast irradiation (AWBI) followed by 3DCRT/IMRT lumpectomy bed boost A External beam boost 3DCRT/IMRT lumpectomy bed boost followed by accelerated whole breast irradiation (AWBI)
- Primary Outcome Measures
Name Time Method Loco-regional control as assessed by physical examination, mammography, and other relevant imaging 5 years
- Secondary Outcome Measures
Name Time Method Toxicity (including seroma formation, brachial plexopathy, fat necrosis, pain, pigmentation, and telangiectasia) as assessed by NCI CTCAE v3.0 5 years Cosmesis as assessed by the Breast Cancer Treatment Outcome Scale 5 years
Trial Locations
- Locations (2)
RWJBarnabas Health - Robert Wood Johnson University Hospital
🇺🇸Somerset, New Jersey, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States