Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01245712|
Recruitment Status : Recruiting
First Posted : November 22, 2010
Last Update Posted : March 27, 2018
The goal of this clinical research study is to find out if receiving a 1-week course of partial breast irradiation (PBI) using proton therapy will cause fewer and/or less severe side effects (such as changes to the appearance of the breast) than a longer course of radiation treatment.
This is an investigational study. Proton radiation therapy is FDA approved and commercially available for breast cancer. Up to 200 women will take part in the study. All will be enrolled at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Accelerated Partial Breast Irradiation (APBI) Behavioral: Questionnaires Device: Proton Therapy System||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation|
|Actual Study Start Date :||November 15, 2010|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Proton-Beam PBI Treatment
Accelerated Partial Breast Irradiation (APBI): Two 3.4 Gy fractions administered per day, separated by at least 6 hours for a total of 34 Gy delivered in 10 fractions (5 - 6 days in a row).
Radiation: Accelerated Partial Breast Irradiation (APBI)
Two 3.4 Gy fractions administered per day, separated by at least 6 hours for a total of 34 Gy delivered in 10 fractions (5 - 6 days in a row).
Questionnaires completed about breast changes at baseline, end of treatment, and at each follow up visit for 10 years.
Other Name: Surveys
Device: Proton Therapy System
Proton beam design will take into account day-to-day variability in treatment set-up and organ motion.
- Patient-Reported Cosmesis Score [ Time Frame: 1 year ]Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.
- Rate of CTCAE Grade 3+ Confluent Moist Desquamation [ Time Frame: Within 6 weeks of radiation therapy ]Rate of CTCAE grade 3+ confluent moist desquamation estimated within 6 weeks of radiation therapy with a 90% credible interval. If we observe CTCAE grade 3+ confluent moist desquamation in only 20 patients, then our 90% credible interval will be 7% to 13%.
- Percent of Patients with Local Failure [ Time Frame: 10 years ]Percent of patients with local failure at 10 years estimated with an exact 95% confidence interval. If there is 1 patient with local failure at 10 years, and researchers have follow-up on all patients at 10 years, then the upper limit of the exact 95% confidence interval will be 2.8%. If researchers don't have 10 years of follow-up on all patients researchers will use the product-limit estimator of Kaplan and Meier (1958) to estimate the local failure rate at 10 years.
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): NCT01245712
|Contact: Eric A. Strom, MD, BS||713-563-2300|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Eric A. Strom, MD, BS|
|Principal Investigator:||Eric A. Strom, MD, BS||M.D. Anderson Cancer Center|