TerminatedNot Applicable

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

Stopped: Internal research admin issue required this study to be closed, will re-open an amended protocol.

United States5 participantsStarted 2021-12-16

Plain-language summary

Prospective, Non-randomized, Single-arm.The objectives of this study are to evaluate cosmesis and perioperative complications associated with the use of intraoperative radiotherapy (IORT) at the time of partial mastectomy in patients with breast cancer and a prior history of radiation therapy. Secondary objectives include evaluating effectiveness of partial mastectomy with IORT, measured by local, regional and distant recurrence, mastectomy rate, and disease-specific and overall survival.

Who can participate

Age range50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥ 50 y.o. * Histologically proven in situ and invasive ductal or lobular breast recurrence * Prior history of whole breast/chest wall radiation therapy * Disease span ≤ 3 cm, unifocal * No nodal disease (N0) * No evidence of metastatic disease (M0) * Time from initial BCT should be ≥ 1 year * Patients have refused the standard of care of mastectomy * Skin distance of ≥ 0.8 cm between applicator and skin Exclusion Criteria: * Multifocal and/or multicenter recurrence * N1-3 status: Regional cytological or histologically proven node recurrence * M1 status: Metastatic disease * cT4 (Skin or muscle involvement) or Paget's disease of the nipple * Patients undergoing mastectomy * Patients undergoing neoadjuvant systemic therapy * Connective tissue disease or scleroderma, contraindicating radiotherapy

What they're measuring

Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.

Timeframe: 5 years

Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.

Timeframe: 5 years

Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale

Timeframe: 5 years

Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.

Timeframe: 5 years

Trial details

NCT IDNCT05289466

SponsorSaint John's Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-23

View on ClinicalTrials.gov More IORT-Intra-Operative Radiation Therapy trials

Plain-language summary

Who can participate

Age range50 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.

Timeframe: 5 years

Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.

Timeframe: 5 years

Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale

Timeframe: 5 years

Perioperative complications as documented using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (CTCAE.v5) scoring system.

Timeframe: 5 years