Synchrotron Radiation to the Treatment of Intracranial Tumors (ESRF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by University Hospital, Grenoble
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT01640509
First received: June 28, 2012
Last updated: November 8, 2013
Last verified: November 2013
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I-II Synchrotron Radiation Application to the Treatment of Intracranial Tumors

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Safety [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    percentage of treated patients compared to the number of patients included

  • Treatment efficacy [ Time Frame: 5 years ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT01640509     History of Changes
Other Study ID Numbers: DCIC 08 06
Study First Received: June 28, 2012
Last Updated: November 8, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on September 18, 2014