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Clinical Trials/NCT02791360
NCT02791360
Completed
Not Applicable

Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor

Centre Francois Baclesse1 site in 1 country15 target enrollmentJanuary 2016
ConditionsBrain Neoplasms

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Neoplasms
Sponsor
Centre Francois Baclesse
Enrollment
15
Locations
1
Primary Endpoint
Proportion of patient with MRI abnormality
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Through this study, the investigators believe to describe more accurately the damage caused by brain radiation therapy in the long term.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
December 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Centre Francois Baclesse
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • In the case group:
  • A history of solid brain tumor or haematological histologically proven.
  • Patients previously treated with radiotherapy in this brain tumor (greater than or equal to 36 Gy dose).
  • Radiotherapy treatment on a tumor in place or operated.
  • Decline at least 10 years from the end of radiotherapy.
  • Treatment with isocentric conformal radiotherapy.
  • No other radiation therapy for locally recurrent brain metastases or new brain tumor.
  • Lack of known brain metastases or meningeal carcinomatosis.
  • For the control group:
  • Patients previously treated for cancer and disease relapse free for 10 years.

Exclusion Criteria

  • In the case group:
  • Brain radiotherapy carried out by intensity modulation technique.
  • Radiation dose less than 36 Gy on the brain.
  • Subject with against-indication to MRI.
  • For the control group:
  • Previous history of brain radiotherapy.
  • Previous history of brain surgery.
  • Central neurological disorders, such as seizures, uncontrolled.
  • For two groups:
  • Current Topics in oral chemotherapy or intravenous.

Outcomes

Primary Outcomes

Proportion of patient with MRI abnormality

Time Frame: up to 4 weeks

To evaluate the proportion of patients with at least one abnormality on an imaging test

Secondary Outcomes

  • MRI diffusion abnormality(up to 4 weeks)
  • MRI perfusion abnormality(up to 4 weeks)
  • MRI vascular morphologic abnormalities(up to 4 weeks)

Study Sites (1)

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