Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer
|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 : July 22, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Adenocarcinoma Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Stage 0 Breast Cancer AJCC v6 and v7 Stage I Breast Cancer AJCC v7 Stage IA Breast Cancer AJCC v7 Stage IB Breast Cancer AJCC v7 Stage II Breast Cancer AJCC v6 and v7 Stage IIA Breast Cancer AJCC v6 and v7 Stage IIB Breast Cancer AJCC v6 and v7||Radiation: Accelerated Partial Breast Irradiation Radiation: Proton Beam Radiation Therapy Other: Quality-of-Life Assessment||Phase 2|
I. To assess the cosmesis, acute toxicity and late toxicity in patients treated with accelerated partial breast irradiation delivered with proton radiation.
I. To evaluate the convenience of accelerated partial breast irradiation and quality of life during accelerated partial breast irradiation.
II. To estimate the in-breast tumor control rates in patients treated with accelerated partial breast irradiation delivered with proton radiation.
III. Compare dosimetry to alternate treatment modalities.
Within 10 weeks of last breast cancer surgery, patients undergo accelerated partial breast irradiation (APBI) delivered with proton radiation twice daily (BID) for 5 days.
After completion of study treatment, patients are followed up at 6 weeks, 6 months, 1 year, and 18 months, then annually for 10 years.
|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: Treatment (APBI)
Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.
Radiation: Accelerated Partial Breast Irradiation
Undergo APBI delivered with proton radiation
Other Name: APBI
Radiation: Proton Beam Radiation Therapy
Undergo APBI delivered with proton radiation
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
- 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, BS,MDemail@example.com|
|United States, Texas|
|M D Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Eric A. Strom 713-563-2300 firstname.lastname@example.org|
|Principal Investigator: Eric A. Strom|
|Principal Investigator:||Eric A Strom||M.D. Anderson Cancer Center|