Intensity Modulated Radiotherapy for Breast Cancer

NCT ID: NCT00594477

Last Updated: 2017-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-04
• Study Completion Date: 2016-08-08

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

IMRT

Intervention Type: RADIATION

Interventions

IMRT

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Imran Zoberi, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

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Related Links

http://www.siteman.wustl.edu

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Other Identifiers

07-1077 / 201106403

Identifier Type: -

Identifier Source: org_study_id