Clinical trial NCT02791360: Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Official title: Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Neoplasms
Keywords: Brain
Radiotherapy
MRI
Sequelae
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2016-06-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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


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.
* No brain radiotherapy treatment.
* Lack of treatment with anti-cancer chemotherapy.
* Women of childbearing potential must be under effective contraception.
* Pairing according to age, sex, arms director and socio-cultural level.

For two groups:

* Man or woman aged (e) of minimum 18 years.
* Topic fluent French and comprising well.
* Free and Informed Consent signed.
* The subject should be affiliated to an appropriate social security system
* No cons-indication to MRI.
* The subject must have at least one primary school level

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.
* Subject pregnant.
* Subject is not fluent in French or including bad.
* Any geographical conditions, social or associated psychopathology that could compromise the patient's ability to participate in the study.
* Participation in a therapeutic trial for less than 30 days.
* A person not affiliated with a social security scheme.

Primary outcomes:
measure: Proportion of patient with MRI abnormality
timeFrame: up to 4 weeks
Secondary outcomes:
measure: MRI diffusion abnormality
timeFrame: up to 4 weeks
measure: MRI perfusion abnormality
timeFrame: up to 4 weeks
measure: MRI vascular morphologic abnormalities
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
Study officials:
References: