Intensity Modulated Radiotherapy for Breast Cancer (IMRT)

The Washington University

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Radiation: IMRT

Study type: Interventional

Funder types: Other

Identifiers

NCT00594477

07-1077 / 201106403

Details and patient eligibility

About

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).

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

IMRT

Experimental group

Description:

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.

Treatment:

Radiation: IMRT