Intensity Modulated Radiotherapy for Breast Cancer

Washington University School of Medicine100 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

IMRTRADIATION

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

Evaluate the feasibility of adjuvant comprehensive radiation therapy via IMRT with daily set-up position verified using 3D verification

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.

Time frame: Within 1 year of protocol registration

Secondary Outcomes

Evaluate the rate and severity of both acute and late cutaneous toxicity

Time frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment

Evaluate the rate and severity of late subcutaneous fibrosis

Time frame: 6-8 months following completion of treatment and 12-14 months following completion of treatment

Evaluate the rate of radiation pneumonitis

Time frame: 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

For patients who receive physical therapy, objective measures of the rotator cuff, bursa, and joint space will be evaluated by diagnostic ultrasound if medically indicated.

Time frame: Pretreatment and 3-4 months following completion of treatment

Evaluate patient quality of life

Data from ClinicalTrials.gov

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