NCT02867423

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	CK Boost radiation	single dose of 8 Grays is issued by the CK to the 6th week after conventional radiation

Timeline

• Start date: 2011-02-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2016-08-16
• Last updated: 2025-09-30

Locations

1 site across 1 country: France