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

NCT ID: NCT02867423

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2018-07-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A - CK boost radiation

CK boost radiation

Group Type: OTHER

CK Boost radiation

Intervention Type: DEVICE

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

Interventions

CK Boost radiation

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre Antoine Lacassagne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre Yves BONDIAU, md

Role: PRINCIPAL_INVESTIGATOR

Centre Antoine Lacassagne

Locations

Centre Antoine LACASSAGNE

Nice, , France

Countries

France

Other Identifiers

2010-A00284-35

Identifier Type: OTHER

Identifier Source: secondary_id

2009/01 CYBERBOOST

Identifier Type: -

Identifier Source: org_study_id