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

Breast Cancer Clinical Trial

— CYBERBOOST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02867423
• Other study ID #: 2009/01 CYBERBOOST
• Status: Completed
• Phase: N/A
• Start date: February 2011
• Est. completion date: July 2018

Study information

• Verified date: November 2017
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
France	Centre Antoine LACASSAGNE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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