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Clinical Trials/NCT03209128
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

Sponsor
Centre Francois Baclesse, Luxembourg
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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