Overview

This trial is active, not recruiting.

Condition breast cancer
Treatment imrt
Phase phase 1
Sponsor Washington University School of Medicine
Start date January 2008
End date June 2016
Trial size 100 participants
Trial identifier NCT00594477, 07-1077 / 201106403

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
imrt

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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
time frame: Pretreatment and 3-4 months following completion of treatment
Evaluate patient quality of life
time frame: Pretreatment, 6-8 months following completion of treatment, and 12-14 months following completion of treatment
Evaluate local-regional control rates
time frame: 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
time frame: 12-14 months following completion of treatment

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Intensity Modulated Radiation Therapy for Breast Cancer: A Phase I Feasibility Study
Principal investigator Imran Zoberi, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.