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Synchrotron Radiation to the Treatment of Intracranial Tumors (ESRF)

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ClinicalTrials.gov Identifier: NCT01640509
Recruitment Status : Recruiting
First Posted : July 13, 2012
Last Update Posted : November 11, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:
The purpose of this study is to prove the safety and acceptability of treatment with the Synchrotron radiation by medium-term medical follow-up of the patients.

Condition or disease Intervention/treatment Phase
Brain Cancer Radiation: treated by synchrotron radiation Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I-II Synchrotron Radiation Application to the Treatment of Intracranial Tumors
Study Start Date : June 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: synchrotron radiation
treated by synchrotron radiation
Radiation: treated by synchrotron radiation
treated by synchrotron radiation



Primary Outcome Measures :
  1. Safety [ Time Frame: 5 years ]
    number of participant with adverse event (grade greater than 2), each adverse event will be gradueted according to Common Terminology Criteria for Adverse Events (CTCAE)Version 4.0


Secondary Outcome Measures :
  1. Survival without limiting adverse events [ Time Frame: 5 years ]
    Evaluate survival without limiting adverse events (EIL) "severe" and "late", related to treatment with score SOMA-LENT (grade greater than 2).

  2. Acceptability [ Time Frame: 2 years ]
    percentage of treated patients compared to the number of patients included

  3. Treatment efficacy [ Time Frame: 5 years ]

    Patients may be enrolled on study with measurable disease based on the RECIST, version 1.1. Disease assessment will be undertaken at baseline and then every month after treatment by MRI. Patients will be evaluated for response according to RECIST, v 1.1 guidelines.

    (Eisenhauer et al. 2009).


  4. Quality of life [ Time Frame: 5 years ]
    assessment with questionnary QLQ C30 and QLQ BN20 of EORTC



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Controlled tumor disease in the primary site and no syndrome metastatic extracranial threatening short-term
  • Presence of 1 to 3 metastases brain symptomatic or not, metachronous primary cancer of a solid, proven itself by histopathological examination
  • In case of multiple lesions sites must be sufficiently spaced so that the PTV can be in separate horizontal planes
  • PS < 2

Exclusion Criteria:

  • One or more lesions > 3 cm in diameter on MRI, or infratentorial location
  • Performed surgical resection or formal indication
  • In progress or finished chemotherapy within the last 4 weeks
  • Partial or total irradiation of brain in the past , or total body irradiation
  • Presence of a second cancer that would be likely to render uncertain the identification of the origin of metastases

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): NCT01640509


Contacts
Contact: Jacques Balosso, MD PhD +33 (0)4 76 76 54 35 JBalosso@chu-grenoble.fr
Contact: François Esteve, MD PhD +33 (0)4 76 76 54 91 esteve@esrf.fr

Locations
France
Esrf / Id17 Recruiting
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jacques Balosso, MD PhD University Hospital, Grenoble

Additional Information:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01640509     History of Changes
Other Study ID Numbers: DCIC 08 06
First Posted: July 13, 2012    Key Record Dates
Last Update Posted: November 11, 2013
Last Verified: November 2013

Keywords provided by University Hospital, Grenoble:
Radiotherapy, Targeted

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases