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Optimizing Preventative Adjuvant Linac-Based Radiation: the OPAL Trial A Phase II Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer

2017-03-13 20:23:22 | BioPortfolio

Summary

The goal of this clinical research study is to learn about the side effects that may occur after radiation is given to breast cancer patients for 2 to 2½ weeks at the part of the breast where the disease first started. Researchers also want to learn if this treatment can help to control the disease and prevent the cancer from coming back in the breast.

Description

If you agree to take part in this study, one (1) time before you begin radiation treatment:

- You will complete 1 questionnaire about how your breast currently looks and feels. It should take about 10 minutes to complete the questionnaires.

- The study team will take pictures of your breast to compare the way it looks before and after you begin receiving radiation. Your face will be covered (as much as possible) and will not be included in the pictures.

Length of Study:

You will receive radiation for 2 to 2½ weeks. You will no longer be able to receive radiation if intolerable side effects occur, or if you are unable to follow study directions. Your participation will be over after the 5-year follow-up visit.

Study Treatment Administration:

If you agree to take part in this study, you will receive about 2 weeks of radiation (10 treatments) to the part of the breast where the disease first started. If the doctor thinks it is needed, you will have 3 additional radiation treatments as a "boost." The boost will be delivered to and focus more closely on the part of the breast where the disease first started.

Follow-Up Visits:

3 weeks after you have finished receiving radiation, you will have a physical exam.

You will return for additional follow-up visits 6 months and 1, 2, 3, 4, and 5 years after you have finished receiving radiation. At each visit:

- You will complete the study questionnaire

- The study team will take pictures of both of your breasts.

- You will have a physical exam.

This is an investigational study. Radiation therapy will be delivered using FDA approved and commercially available methods. The shorter radiation treatment period is considered investigational. The study doctor can explain how radiation is designed to work.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Study Design

Conditions

Malignant Neoplasm of Breast

Intervention

External Radiation Therapy, Questionnaires

Location

University of Texas MD Anderson Cancer Center
Houston
Texas
United States
77030

Status

Recruiting

Source

M.D. Anderson Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-03-13T20:23:22-0400

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