Hypofractionated Radiation by CyberKnife as a Mean of the Tumor Site's Radiation 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Antoine LACASSAGNE

Nice, 06189, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CK Boost radiation

Device

single dose of 8 Grays is issued by the CK to the 6th week after conventional radiation

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Centre Antoine Lacassagne

Other

Registry information

Official study title

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

Acronym: CYBERBOOST

Important dates

Study start: 2011
Primary completion: 2018
Study completion: 2018
First posted: Aug 16, 2016
Registry last updated: Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed