We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Synchrotron Radiation to the Treatment of Intracranial Tumors (ESRF)

This study is currently recruiting participants.
Verified November 2013 by University Hospital, Grenoble
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640509
First Posted: July 13, 2012
Last Update Posted: November 11, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Grenoble
  Purpose
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 Intervention Phase
Brain Cancer Radiation: treated by synchrotron radiation Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • 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:
  • 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).

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

  • 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).


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


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: synchrotron radiation
treated by synchrotron radiation
Radiation: treated by synchrotron radiation
treated by synchrotron radiation

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Additional Information:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01640509     History of Changes
Other Study ID Numbers: DCIC 08 06
First Submitted: June 28, 2012
First Posted: July 13, 2012
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