Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
Study Overview
Brief Summary
This study delivers radiation therapy to any residual breast tissue and the chest wall plus lymph node areas around the breast. These lymph node areas are under the arm, around the collar bone, and under the sternum (breastbone).
Detailed Description
IMRT treatment uses a computer-controlled x-ray (CT) to deliver radiation beams at several different angles and strengths to deliver precise doses to the regions at risk for recurrence of breast cancer while reducing or sparing the dose to critical structures (heart, lungs) and nearby normal tissue.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female gender
- •Age ≥ 18 years
- •Invasive primary female breast cancer
- •Pathologically proven regional nodal metastasis
- •Status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection.
- •Signed study specific consent form
Exclusion Criteria
- •Distant metastasis
- •Currently Pregnant
- •Psychiatric or addictive disorders that preclude informed consent
- •Time from initial diagnosis to the start of radiation therapy > one year
- •Estimated life expectancy judged to be < one year
- •Prior radiation to the ipsilateral breast or chest wall
- •Primary breast cancer is lymphoma or sarcoma
- •Patients being treated with concurrent chemotherapy.
Arms & Interventions
IMRT
The prescribed dose for all patients will be 5040 cGy in 28 fractions. Patients will receive external beam treatment once a day, five days a week for approximately five and a half weeks.
Intervention: IMRT (Radiation)
Outcomes
Primary Outcomes
Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification
Time Frame: Within 1 year of protocol registration
The study will be deemed infeasible if greater than 10% of enrolled patients have at least one of the following outcomes: 1. Patient cannot be given the treatment because her anatomy is such that a dosimetrically satisfactory treatment plan cannot be devised for her. 2. Within 1 year of protocol registration, the patient develops radiation pneumonitis toxicity of greater than or equal to grade 3 by CTCAE scales. 3. Within 1 year of protocol registration, the patient develops any local or regional breast cancer recurrence. 4. Within 1 year of protocol registration, the patient dies from causes judged to be related to her treatment.
Secondary Outcomes
- Evaluate the rate of radiation pneumonitis(6-8 weeks following completion of treatment, 3-4 months following completion of treatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment)
- Evaluate ipsilateral upper quadrant function(Pretreatment and 3-4 months following completion of treatment)
- Evaluate patient quality of life(Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment)
- Evaluate the rate and severity of both acute and late cutaneous toxicity(6-8 months following completion of treatment and 12-14 months following completion of treatment)
- Evaluate local-regional control rates(12-14 months following completion of radiation therapy)
- Evaluate patient set-up reproducibility in breast cancer patients treated with IMRT using daily 3D position verification(12-14 months following completion of treatment)
- Evaluate the rate and severity of late subcutaneous fibrosis(6-8 months following completion of treatment and 12-14 months following completion of treatment)