Optimizing Preventative Adjuvant Linac-Based Radiation: the OPAL Trial - Study of Hypofractionated Partial Breast Irradiation in Women With Early Stage Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03077841|
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : August 17, 2018
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.
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 150 participants will be enrolled in this multicenter study.
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Breast Breast Cancer||Radiation: External Radiation Therapy Behavioral: Questionnaires||Phase 2|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Experimental: Hypofractionated Partial Breast Irradiation
Participants receive about 2 weeks of radiation (10 treatments) to the part of the breast where the disease first started.
Questionnaires completed at baseline and at 6 months and 1, 2, 3, 4, and 5 years after receiving radiation.
Radiation: External Radiation Therapy
Prescription dose is 35 Gy in 10 daily fractions delivered on consecutive treatment days. A treatment day is defined as a normal business day, typically Monday - Friday excluding institutional holidays. A 3 Gy in 3 fraction boost should be delivered if a close (less than 2 mm) margin is present and should not be delivered if margins are negative at a minimum of 2 mm or greater.
Questionnaires completed at baseline, and at 6 months and 1, 2, 3, 4, and 5 years after receiving radiation. Questionnaires ask about how participant's breast currently looks and feels. It should take about 10 minutes to complete the questionnaires.
Other Name: Surveys
- Rate of grade 2 or Higher Treatment Toxicity with Optimizing Preventative Adjuvant Linac-Based Radiation (OPAL) Regimen [ Time Frame: Toxicity measured from the start of radiation through the 6 month follow up visit. ]Toxicity during the course of radiotherapy as determined by the treating physician.
- Patient-Reported Cosmetic Outcome with Optimizing Preventative Adjuvant Linac-Based Radiation (OPAL) Regimen [ Time Frame: Baseline and 6 months and 1, 2, 3, 4, and 5 years after receiving radiation ]Breast Cancer Treatment Outcomes Scale (BCTOS) used to score cosmetic outcome from 1 to 4, with a score of 2.5 or higher indicating adverse cosmetic outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077841
|Contact: Benjamin Smith, MDfirstname.lastname@example.org|
|United States, Indiana|
|Community Health Network||Recruiting|
|Indianapolis, Indiana, United States, 46256|
|United States, New Jersey|
|Cooper University Healthcare||Recruiting|
|Camden, New Jersey, United States, 08103|
|United States, Ohio|
|Ohio Health/Presbyterian MDA Radiation Treatment Center||Recruiting|
|Columbus, Ohio, United States, 43228|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Summit Medical Group||Recruiting|
|Houston, Texas, United States, 77051|
|MD Anderson Cancer Center at Bay Area||Recruiting|
|Houston, Texas, United States, 77058|
|MD Anderson Cancer Center at Katy||Recruiting|
|Houston, Texas, United States, 77094|
|San Antonio, Texas, United States, 78229|
|MD Anderson Cancer Center at Sugar Land||Recruiting|
|Sugar Land, Texas, United States, 77478|
|University of Texas MD Anderson Cancer Center at The Woodlands||Recruiting|
|The Woodlands, Texas, United States, 77384|
|Principal Investigator:||Benjamin Smith, MD||M.D. Anderson Cancer Center|