NCT03209128TerminatedNot Applicable
Savings of Hippocampus and Amygdala by Archetherapy in Cerebral Prophylactic Irradiation in Patients With Limited and / or Extended, Responsive or Stable Small Cell Lung Cancer (SCLC)
Centre Francois Baclesse, Luxembourg1 site in 1 country11 target enrollmentStarted: April 20, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Cognitive function
Study Overview
Brief Summary
Hippocampus and amygdala are parts of the brain involved in the recognition of emotions, memories, memory, language ... It is therefore very important to protect them during irradiation of the brain.
The aim of this study is to evaluate cerebral irradiation with saving hippocampus and amygdala protects these brain functions in patients with small cell lung cancer (SCLC) Radiotherapy of the brain
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients over 18 years of age
- •Patients with a limited SCLC demonstrated histologically responsive or stable to radiochemotherapy or patients with a histologically proven extended SCLC responding to chemotherapy.
- •WHO Performance Index 0-1 and / or Karnovsky Index> 70
- •Possibility of long-term monitoring
Exclusion Criteria
- •Concomitant chemotherapy
- •Impossibility of performing an MRI or CT without injection
- •Presence of cerebral metastases
- •History of cerebral irradiation at any time
- •Patient suffering from severe collagenosis
- •Patient with cognitive disorders with MMSE score <24
Outcomes
Primary Outcomes
Cognitive function
Time Frame: until 18 months after inclusion of patient
Evaluate the cognitive function with Wechsler Memory Scale IV (WMS-IV) test
Secondary Outcomes
- Appearance of brain metastases and their location(until 18 months after inclusion of patient)
- Secondary effects according the CTCAE v.4 criteria(until 18 months after inclusion of patient)
- Quality of life (QOL) of patients(until 18 months after inclusion of patient)
Investigators
Study Sites (1)
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