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

Centre Francois Baclesse

Status: Completed

Conditions: Brain Neoplasms

Treatments: Other: Brain MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02791360

TCSEQ

Details and patient eligibility

About

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

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

MRI evaluation

Other group

Description:

Patient pretreated for brain tumor and witness

Treatment:

Other: Brain MRI