Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala

Terminated

• Conditions: Non Small Cell Lung Cancer
• Interventions: Radiation: Irradiation prophyllactique cérébrale

• Registration Number: NCT03209128
• Lead Sponsor: Centre Francois Baclesse, Luxembourg

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Study First Submitted: 2017-06-30
• Study First Submitted QC: 2017-07-03
• Study First Posted: 2017-07-06
• Primary Completion: 2019-12-31
• Study Completion: 2021-03-19
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-20
• Last Update Posted: 2022-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Irradiation prophyllactique cérébrale	Irradiation prophyllactique cérébrale	-

Primary Outcome Measures

Name	Time	Method
Cognitive function	until 18 months after inclusion of patient	Evaluate the cognitive function with Wechsler Memory Scale IV (WMS-IV) test

Secondary Outcome Measures

Name	Time	Method
Appearance of brain metastases and their location	until 18 months after inclusion of patient	Evaluate the brain control with brain MRI
Secondary effects according the CTCAE v.4 criteria	until 18 months after inclusion of patient	Evaluate the toxicity according the CTCAE v.4 criteria
Quality of life (QOL) of patients	until 18 months after inclusion of patient	Evaluate QOL with FACT-BR test (Functional Assessment of Cancer Therapy-Brain)

Trial Locations

Locations (1)

Centre Francois Baclesse; 🇱🇺 Esch Sur Alzette, Luxembourg