Synchrotron Radiation to the Treatment of Intracranial Tumors
ESRF
A Phase I-II Synchrotron Radiation Application to the Treatment of Intracranial Tumors
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2012
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 28, 2012
CompletedFirst Posted
Study publicly available on registry
July 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedNovember 11, 2013
November 1, 2013
2 years
June 28, 2012
November 8, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety
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
5 years
Secondary Outcomes (4)
Survival without limiting adverse events
5 years
Acceptability
2 years
Treatment efficacy
5 years
Quality of life
5 years
Study Arms (1)
synchrotron radiation
EXPERIMENTALtreated by synchrotron radiation
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Esrf / Id17
Grenoble, 38000, France
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacques Balosso, MD PhD
University Hospital, Grenoble
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 28, 2012
First Posted
July 13, 2012
Study Start
June 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2019
Last Updated
November 11, 2013
Record last verified: 2013-11