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

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ClinicalTrials.gov Identifier: NCT02867423
Recruitment Status : Completed
First Posted : August 16, 2016
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: CK Boost radiation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02867423


Locations
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France
Centre Antoine LACASSAGNE
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
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Principal Investigator: Pierre Yves BONDIAU, md Centre Antoine Lacassagne

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Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT02867423     History of Changes
Other Study ID Numbers: 2009/01 CYBERBOOST
First Posted: August 16, 2016    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided