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

Centre Antoine Lacassagne

Status: Completed

Conditions: Breast Cancer

Treatments: Device: CK Boost radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT02867423

2009/01 CYBERBOOST

Details and patient eligibility

About

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.

Enrollment: 29 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

A - CK boost radiation

Other group

Description:

CK boost radiation

Treatment:

Device: CK Boost radiation