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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02867423

Acronym

CYBERBOOST

Enrollment

Registered

2016-08-16

Start date

2011-02-01

Completion date

2018-07-01

Last updated

2026-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

DEVICECK Boost radiation

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORPierre Yves BONDIAU, md

Centre Antoine Lacassagne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 24, 2026