Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Last updated: August 11, 2022
Sponsor: Institut Català d'Oncologia
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT05498311
IORT BREAST CANCER
  • Ages > 45
  • Female
  • Accepts Healthy Volunteers

Study Summary

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility forconservative surgery (with or without oncoplastic surgery) and radiotherapy.
  • Not pregnant at diagnosis.
  • Signed informed consent form.
  • Age ≥45 years old.
  • Patients candidates to Intrabeam.
  • Patients with ≥60 years with the presence of one or more of the following adversecriteria after surgery:
  • Tumor size > 2.5 cm.
  • Extensive intraductal carcinoma (≥25%)
  • Lymphovascular invasion.
  • Involved focal margins (<2mm) without ampliation surgery.

Exclusion

Exclusion Criteria:

  • Presence of distant metastasis.
  • Primary chemotherapy.
  • Lymph node involvement.
  • Negative hormonal receptors.
  • Diagnosis of any other infiltrating tumour except for adequately resected squamous orbasal cell epitheliomas
  • Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma,dermatomyositis).
  • Uncontrolled infection.
  • Concurrent treatment with other experimental treatments
  • Lack of signed informed consent form.

Study Design

Total Participants: 89
Study Start date:
October 20, 2016
Estimated Completion Date:
December 31, 2024

Study Description

To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Connect with a study center

  • Evelyn Martínez

    Hospitalet de Llobregat, Barcelona 08908
    Spain

    Active - Recruiting

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