Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boca Raton Regional Hospital Foundation | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Breast Irradiation (PBI) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensity modulated radiation therapy (IMRT) | Radiation | 40 Gy total in 15 consecutive weekday sessions to the partial breast |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of grade 3 or higher treatment-related adverse events (AEs) | Adverse events will be collected using Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) starting from the first radiation treatment. Grade 1 AEs are considered mild, grade 2 AEs are considered moderate, grade 3 AEs are considered severe, grade 4 AEs are considered life-threatening, and grade 5 AEs are considered fatal. The percentage of participants experiencing grade 3 or higher treatment-related AEs will be calculated. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence-free survival (LRFS) | Local recurrence is defined as tumor recurrence in the reirradiated region. LRFS is defined as time from the start of radiation treatment to local recurrence or death, whichever occurs first, and will be estimated by Kaplan-Meier method. Participants who do not have local recurrence and are still alive will be censored to their final follow-up date. | 5 years |
Not provided
Inclusion Criteria:
A person able to become pregnant is any person assigned female at birth (regardless of gender identity, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Youssef Zeidan, M.D., Ph.D. | Contact | (561) 955-5966 | youssef.zeidan@baptisthealth.net | |
| MCI Multisite Research Program | Contact | MCIMultiSiteResearch@baptishealth.net |
| Name | Affiliation | Role |
|---|---|---|
| Youssef Zeidan, M.D., Ph.D. | Lynn Cancer Institute at Baptist Health, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lynn Cancer Institute at Baptist Health, Inc. | Recruiting | Boca Raton | Florida | 33486 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31750868 | Background | Arthur DW, Winter KA, Kuerer HM, Haffty B, Cuttino L, Todor DA, Anne PR, Anderson P, Woodward WA, McCormick B, Cheston S, Sahijdak WM, Canaday D, Brown DR, Currey A, Fisher CM, Jagsi R, Moughan J, White JR. Effectiveness of Breast-Conserving Surgery and 3-Dimensional Conformal Partial Breast Reirradiation for Recurrence of Breast Cancer in the Ipsilateral Breast: The NRG Oncology/RTOG 1014 Phase 2 Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):75-82. doi: 10.1001/jamaoncol.2019.4320. | |
| 28721885 |
| Label | URL |
|---|---|
| Lynn Cancer Institute at Baptist Health, Inc. | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Overall survival (OS) | OS is defined as the time from the start of radiation treatment to death and will be estimated by Kaplan-Meier method. Participants who are still alive will be censored to their final follow-up date. | 5 years |
| Distant metastasis-free survival (DMFS) | Distant metastasis is defined as cancer spreading to other areas of the body. DMFS is defined as the time from the start of radiation treatment to time of distant metastasis or death and will be estimated by Kaplan-Meier method. Participants who do not have distant metastasis and are still alive will be censored to their final follow-up date. | 5 years |
| Mastectomy-free survival (MFS) | MFS is defined as the time from the start of radiation treatment to mastectomy or death, whichever occurs first, and will be estimated by Kaplan-Meier method. Participants who have not had a mastectomy and are still alive will be censored to their final follow-up date. | 5 years |
| Change in patient-rated cosmesis | Assessed using the National Surgical Adjuvant Breast and Bowel Project (NSABP) B39.0 questionnaire. Physical appearance. 22 questions, rated 1 (no difference between breasts) to 4 (large difference). Range 22-88 (worse). Recovery. 8 questions, rated 0 (not at all) to 10 (a lot). In 7 questions, higher is worse; scoring will be reversed for 1 item. Range 0-80 (worse). Feelings. 4 questions, rated 1 (all the time) to 5 (none of the time). Lower is better for 2 but worse for 2. Scoring for 2 items will be reversed. 4 questions related to pain rated from 0 (no pain) to 10 (worst pain). Range 0-40 (worse). One question is about pain treatment. Bothered. 27 questions, rated 0 (not at all) to 4 (very much). Range 0 -108 (worse). Satisfaction. Appearance of the treated breast rated from 1 (excellent) to 4 (poor). Satisfaction rated on a 5-item scale from totally satisfied to totally dissatisfied. Breast size before and after treatment: left larger, same, right larger. | Over 5 years |
| Miami Cancer Institute at Baptist Health, Inc. | Recruiting | Miami | Florida | 33176 | United States |
|
| Background |
| Arthur DW, Winter KA, Kuerer HM, Haffty BG, Cuttino LW, Todor DA, Simone NL, Hayes SB, Woodward WA, McCormick B, Cohen RJ, Sahijdak WM, Canaday DJ, Brown DR, Currey AD, Fisher CM, Jagsi R, White J. NRG Oncology-Radiation Therapy Oncology Group Study 1014: 1-Year Toxicity Report From a Phase 2 Study of Repeat Breast-Preserving Surgery and 3-Dimensional Conformal Partial-Breast Reirradiation for In-Breast Recurrence. Int J Radiat Oncol Biol Phys. 2017 Aug 1;98(5):1028-1035. doi: 10.1016/j.ijrobp.2017.03.016. Epub 2017 Mar 18. |
| 23835717 | Background | Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8. |
| Miami Cancer Institute at Baptist Health, Inc. | View source |