MRI-Based Preoperative Accelerated Partial Breast Irradiation
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|ClinicalTrials.gov Identifier: NCT02728076|
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : October 30, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Phase II - Preoperative Radiation followed by Lumpectomy.||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2024|
Experimental: Radiation Therapy followed by Lumpectom
Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy
Other: Phase II - Preoperative Radiation followed by Lumpectomy.
Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.
- Postoperative Complication Rates following Preoperative APBI [ Time Frame: 4 Months ]
Postoperative complications (the primary endpoint of the study) will be defined as any complication occurring within three months of surgery. These will be measured by CTCAE.
The complication rate measured on this study will be compared to a historical control of 32% of patients. This will be measured on an individual patient level. A surgical complication rate that exceeds 31% will be considered unacceptable and result in a negative study. A postoperative complication rate of 14% or less will be considered a successful demonstration of the safety of this treatment.
- Cosmetic Outcomes [ Time Frame: 5 Years ]Cosmesis will be judged by the patient, radiation oncologist and/or surgeon, at stated follow-up intervals. Cosmetic assessments will be assessed using a 4-point scale.
- Measure Rates of Fibrosis and Pain [ Time Frame: 5 Years ]Patient reported average and worst pain in the treated breast. Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Scheme, rate of Grade 2+ subcutaneous fibrosis. (Statistics: Kaplan-Meier survival estimates or estimate of the cumulative incidence rate will be used where censoring or competing risks occur (local control, cosmetic outcomes, fibrosis, and pain).)
- Rates of Re-excision [ Time Frame: 5 Years ]The need for surgical re-excision after the initial lumpectomy because of close or positive margins will be determined by the treating surgeon and radiation oncologist. For any patient with a positive margin, re-excision is required unless technically not possible (i.e. poor anesthesia risk for the patient, inability to resect additional breast tissue at the site of the positive margin). The re-excision rate and rate of partial/complete response with be estimated with exact confidence intervals, and compared to historical controls using Chi-Square or Fisher's exact tests.
- Overall Survival [ Time Frame: 5 Years ]A final analysis will occur when all patients have been followed up for five years. Record long term outcomes of local recurrence rates and overall survival of patients treated with this modality.
- Feasibility of MRI-based Treatment Planning [ Time Frame: 5 Years ]Demonstrate the feasibility of MRI-based treatment planning for preoperative APBI and compare dosimetric data from treatment planning with patients treated on a previous institutional post-op APBI protocol.
- Local Control [ Time Frame: 5 Years ]Local tumor control defined as reappearance of the tumor in the ipsilateral breast.
- Radiologic and Pathologic Response [ Time Frame: 5 Years ]Tumor response will be assessed using the RECIST and mRECIST criteria.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728076
|Contact: Medical College of Wisconsin Cancer Centeremail@example.com|
|United States, Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Meena Bedi, MD|
|Contact: Cancer Center Clinical Trials 1-866-680-0505 ext 8900 firstname.lastname@example.org|
|Medical College of Wisconsin Cancer Center||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Adam Currey, MD 414-805-4400 email@example.com|
|Contact: Carmen Bergom, MD 414-805-4400 firstname.lastname@example.org|
|Principal Investigator:||Adam Currey, MD||Medical College of Wisconsin|