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

NCT ID: NCT02791360

Last Updated: 2018-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

Brief Summary

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

Conditions

Brain Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

MRI evaluation

Patient pretreated for brain tumor and witness

Group Type: OTHER

Brain MRI

Intervention Type: OTHER

Interventions

Brain MRI

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Francois Baclesse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre François Baclesse

Caen, , France

Countries

France

Other Identifiers

TCSEQ

Identifier Type: -

Identifier Source: org_study_id