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Trial Title: Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

NCT ID: NCT05498311

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Intraoperative radiotherapy
hypofractionated radiotherapy

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Intraoperative Radiotherapy (IORT)

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: Intraoperative Radiotherapy (IORT)
Description: The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
Arm group label: Intraoperative Radiotherapy (IORT)

Intervention type: Procedure
Intervention name: Breast conservative surgery
Description: Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
Arm group label: Intraoperative Radiotherapy (IORT)

Intervention type: Radiation
Intervention name: External Beam Hypofractionated Radiotherapy (EBRT)
Description: A External Beam Hypofractionated Radiotherapy will be administered after surgery. y. The dose per fraction will be 2.67 Gy per session. EBRT will be performed daily from Monday to Friday for fifteen fractions.
Arm group label: Intraoperative Radiotherapy (IORT)

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

Detailed 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

Criteria for eligibility:
Criteria:
Inclusion Criteria: - Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative 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 adverse criteria after surgery: - Tumor size > 2.5 cm. - Extensive intraductal carcinoma (≥25%) - Lymphovascular invasion. - Involved focal margins (<2mm) without ampliation surgery. 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 or basal 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.

Gender: Female

Minimum age: 45 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Evelyn Martínez

Address:
City: Hospitalet de Llobregat
Zip: 08908
Country: Spain

Status: Recruiting

Contact:
Last name: Evelyn Martínez, MD

Phone: +34 93 260 77 20
Email: emperez@iconcologia.net

Start date: October 20, 2016

Completion date: December 2024

Lead sponsor:
Agency: Institut Català d'Oncologia
Agency class: Other

Source: Institut Català d'Oncologia

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05498311

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