NCT05498311

Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

Cosmetic Outcomes Following Conservative Surgery (With or Without Oncoplastic Surgery) for Breast Cancer With Intraoperative Radiotherapy (INTRABEAM) Followed by Hypofractionated External Beam Radiotherapy: a Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (estimated)
• Sponsor: Institut Català d'Oncologia · Academic / Other
• Sex: Female
• Age: 45 Years
• Healthy volunteers: Accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Intraoperative Radiotherapy (IORT)	The Intrabeam Photon Radiosurgery System will deliver 20 Gy in the act of breast surgery
PROCEDURE	Breast conservative surgery	Breast conservative surgery with the aim of resecting breast tumour and with or without oncoplastic surgery
RADIATION	External Beam Hypofractionated Radiotherapy (EBRT)	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.

Timeline

• Start date: 2016-10-20
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2022-08-12
• Last updated: 2022-08-15

Locations

1 site across 1 country: Spain