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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02791360
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : January 26, 2018
Information provided by (Responsible Party):
Centre Francois Baclesse

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

Condition or disease Intervention/treatment Phase
Brain Neoplasms Other: Brain MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation of Anatomy, Clinical and Neuropsychological Long-term Sequelae of Patients Treated With Radiation Therapy for Brain Tumor
Study Start Date : January 2016
Actual Primary Completion Date : September 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
MRI evaluation
Patient pretreated for brain tumor and witness
Other: Brain MRI

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. MRI diffusion abnormality [ Time Frame: up to 4 weeks ]
  2. MRI perfusion abnormality [ Time Frame: up to 4 weeks ]
  3. MRI vascular morphologic abnormalities [ Time Frame: up to 4 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02791360

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Centre François Baclesse
Caen, France, 14400
Sponsors and Collaborators
Centre Francois Baclesse

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Responsible Party: Centre Francois Baclesse Identifier: NCT02791360     History of Changes
Other Study ID Numbers: TCSEQ
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018
Keywords provided by Centre Francois Baclesse:
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases