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

NCT02867423 | Completed DMC

• 2 other identifiers: 2009/01 CYBERBOOST2010-A00284-35
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• EORTC score for erythema, telangiectasia, edema, pain

  early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain.

  2 months

Study Arms (1)

A - CK boost radiation

OTHER

CK boost radiation

Device: CK Boost radiation

Interventions

CK Boost radiation DEVICE

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

A - CK boost radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine LACASSAGNE

Nice, 06189, France

Location

Related Publications (1)

• Bondiau PY, Gal J, Chapellier C, Haudebourg J, Courdi A, Levy J, Gerard A, Sumodhee S, Maurin M, Chateau Y, Barranger E, Ferrero JM, Thariat J. Robotic Stereotactic Boost in Early Breast Cancer, a Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2019 Feb 1;103(2):374-380. doi: 10.1016/j.ijrobp.2018.09.020. Epub 2018 Oct 26.

  PMID: 30612961 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Pierre Yves BONDIAU, md

  Centre Antoine Lacassagne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: February 1, 2011
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)