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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: CK Boost radiation

• Registration Number: NCT02867423
• Lead Sponsor: Centre Antoine Lacassagne

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2016-08-11
• Study First Submitted QC: 2016-08-15
• Study First Posted: 2016-08-16
• Status Verified: 2017-11
• Primary Completion: 2018-07
• Study Completion: 2018-07
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A - CK boost radiation	CK Boost radiation	CK boost radiation

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Centre Antoine LACASSAGNE; 🇫🇷 Nice, France