Hypofractionated Radiation by CyberKnife as a Mean of the Tumor Site's Radiation After Conventional Breast Radiation. (CYBERBOOST)
|ClinicalTrials.gov Identifier: NCT02867423|
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : August 8, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Device: CK Boost radiation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PHASE II STUDY : Hypofractionated Radiation by CyberKnife as a Mean of Radiation of the Tumor Site After Conventional Breast Radiation.|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||July 2018|
|Actual Study Completion Date :||July 2018|
A - CK boost radiation
CK boost radiation
Device: CK Boost radiation
single dose of 8 Grays is issued by the CK to the 6th week after conventional radiation
- EORTC score for erythema, telangiectasia, edema, pain [ Time Frame: 2 months ]early skin toxicity evaluation by clinical examination (radiation oncology and dermatologist) using EORTC score for erythema, telangiectasia, edema, pain.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867423
|Centre Antoine LACASSAGNE|
|Nice, France, 06189|
|Principal Investigator:||Pierre Yves BONDIAU, md||Centre Antoine Lacassagne|