Intraoperative Electron Beam Radiotherapy Boost in Treating Patients With Stage I-II Breast Cancer Undergoing Surgery With Reconstruction
|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: NCT02927912|
Recruitment Status : Recruiting
First Posted : October 7, 2016
Last Update Posted : December 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer||Radiation: Electron Beam Therapy Procedure: Lumpectomy Other: Quality-of-Life Assessment Other: Questionnaire Administration Radiation: Radiation Therapy Procedure: Reconstructive Surgery||Phase 2|
I. To determine the rate of grade 3 breast fibrosis at 1 year in women undergoing lumpectomy with oncoplastic reconstruction and immediate intraoperative electron radiotherapy boost followed by adjuvant whole breast radiotherapy.
I. To determine the rate of 5 year ipsilateral breast tumor recurrence rate. II. To determine the change in self-reported cosmesis using the Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire.
III. To evaluate physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs.
Patients undergo standard of care lumpectomy and then undergo 1 fraction of intraoperative electron beam radiation therapy (IOERT) boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
After completion of study treatment, patients are followed up at 1 month, 6 months, 1 year, and every year thereafter for 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||176 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multi-institution Phase II Trial of Intraoperative Electron Beam Radiotherapy Boost at the Time of Breast Conserving Surgery With Oncoplastic Reconstruction in Women With Early-Stage Breast Cancer|
|Actual Study Start Date :||March 23, 2017|
|Estimated Primary Completion Date :||November 1, 2020|
|Estimated Study Completion Date :||November 1, 2022|
Experimental: Treatment (IOERT boost)
Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.
Radiation: Electron Beam Therapy
Undergo IOERT boost
Other Name: photon beam radiation therapy
Other: Quality-of-Life Assessment
Other Name: Quality of Life Assessment
Other: Questionnaire Administration
Radiation: Radiation Therapy
Undergo whole breast radiation therapy
Procedure: Reconstructive Surgery
Undergo oncoplastic reconstruction
Other Name: Reconstruction
- Incidence of adverse events in the first 30 patients enrolled as graded by the National Cancer Institute Common Toxicity Criteria version 4.0 [ Time Frame: Up to 30 days after surgery and IOERT boost ]If 4 or more complications in the first 10 patients, 7 or more out of the first 20 patients or 9 or more out of 30 patients are observed, then the study will be deemed not safe to continue. Summary statistics will be used to report all complications.
- Rate of grade 3 fibrosis using the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales [ Time Frame: At 1 year from the end of therapy ]The proportion of patients with an overall response rate of grade 3 fibrosis at 1 year from the end of therapy along with the exact binomial confidence interval for the rate will be calculated.
- Change in self-reported cosmesis using the BCTOS [ Time Frame: Baseline up to 3 years ]The mean and standard deviation of the self-reported cosmesis using the BCTOS cosmesis scale will be summarized over time. The change over time using a repeated measures model or non-parametric methods, if appropriate, will be examined.
- Physician reported cosmesis using the Harvard Breast Cosmesis scale and digital photographs [ Time Frame: Up to 3 years after completion of radiation therapy ]physician-reported cosmetic outcomes using the 4-point Harvard Cosmesis Scale and digital photographs
- Quality of life assessed by Breast Cancer Treatment Outcome Scale [ Time Frame: Up to 3 years after completion of radiation therapy ]determine the rate of surgical complications necessitating hospital readmission or return to the operating room within 30 days of surgery + IOERT
- Rate of ipsilateral breast tumor recurrence [ Time Frame: At 5 years ]The exact binomial confidence interval for the rate will be calculated.
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): NCT02927912
|Contact: The Ohio State University Comprehensive Cancer Center||800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Sohyun McElroyfirstname.lastname@example.org|
|United States, North Carolina|
|University of North Carolina||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Zahra Mahbooba, BA, CCRC 984-974-8744 email@example.com|
|Principal Investigator: Gaorav Gupta, MD, PhD|
|United States, Ohio|
|Ohio State University Comprehensive Cancer Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Jose G. Bazan, MD, MS 614-688-7371 firstname.lastname@example.org|
|Principal Investigator: Jose G. Bazan|
|United States, South Dakota|
|Avera Cancer Institute||Recruiting|
|Sioux Falls, South Dakota, United States, 57105|
|Contact: Cheryl Ageton, RN 605-322-3095 email@example.com|
|Principal Investigator: Kyle Arneson, MD|
|Principal Investigator:||Jose Bazan, MD, MS||Ohio State University Comprehensive Cancer Center|