Hypofractionated Radiation by CyberKnife as a Mean of the Tumor Site's Radiation After Conventional Breast Radiation. (CYBERBOOST)

April 20, 2026 updated by: Centre Antoine Lacassagne

PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.

The CyberKnife (CK) has been developed recently. This is a linear accelerator carried by an industrial robot. It has, due to its tumor tracking capabilities and high accuracy, an interest in irradiation (boost) of tumor site after conventional irradiation. The radiation boost is currently issued by electrons, protons or brachytherapy. These techniques require several fractions and are associated with cutaneous toxicities and aesthetic problems. CK has an interest in reducing the number of fractions and a reduction of dose delivered to the skin.

CK has been used in a phase I protocol (CYBERNEO) with concomitant chemotherapy for inoperable breast tumors and has proven its effectiveness and safety of treatments.

The investigator is considering conducting a Phase II protocol to a single dose of 8 Grays issued by CK for boost to the tumor site after conventional breast irradiation.

The results, in terms of local control, will be evaluated on clinical monitoring.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06189
        • Centre Antoine Lacassagne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. unifocal breast cancer histologically proven
  2. Age> 18 years old, in good general condition (ECOG 0-2)
  3. No cons-indication for radiotherapy
  4. Patient who underwent lumpectomy and axillary dissection or sentinel node technique.
  5. carcinoma histology ductal or lobular carcinoma
  6. surgical margins microscopically without residual disease (> 1 mm)
  7. tumors classes T1 or T2, N0

Exclusion criteria

  1. residual calcifications on X-ray examination
  2. Inflammatory breast cancer, ductal (and / or in situ) and invasive lobular
  3. multifocal breast Cancer
  4. prior Breast radiotherapy
  5. Patient who received chemotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A - CK boost radiation
CK boost radiation
Device: CK Boost radiation
single dose of 8 Grays is issued by the CK to the 6th week after conventional radiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EORTC score for erythema, telangiectasia, edema, pain
Time Frame: 2 months
early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Antoine Lacassagne

Investigators

  • Principal Investigator: Pierre Yves BONDIAU, md, Centre Antoine Lacassagne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

July 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 15, 2016

First Posted (Estimated)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 20, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/01 CYBERBOOST
  • 2010-A00284-35 (Other Identifier: AFSSAPS ID RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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