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

Brain Neoplasms Clinical Trial

— TCSEQ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02791360
• Other study ID #: TCSEQ
• Status: Completed
• Phase: N/A
• First received: May 17, 2016
• Last updated: January 25, 2018
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: January 2018
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms

Intervention

Other:
• Brain MRI

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patient with MRI abnormality	To evaluate the proportion of patients with at least one abnormality on an imaging test	up to 4 weeks
Secondary	MRI diffusion abnormality		up to 4 weeks
Secondary	MRI perfusion abnormality		up to 4 weeks
Secondary	MRI vascular morphologic abnormalities		up to 4 weeks