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

S

Saint John's Cancer Institute

Status

Enrolling

Conditions

IORT-Intra-Operative Radiation Therapy

Treatments

Procedure: Oncoplastic partial mastectomy
Radiation: Intraoperative Radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05289466
JWCI OBCS WITH IORT

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

Single-arm
Other group
Description:
Intraoperative Radiotherapy (Xoft, 20 Gy single dose)
Treatment:
Procedure: Oncoplastic partial mastectomy
Radiation: Intraoperative Radiotherapy

Trial contacts and locations

1

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Central trial contact

Robert Wollman, MD; Janie Weng Grumley, MD

Data sourced from clinicaltrials.gov

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