Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala

Non Small Cell Lung Cancer Clinical Trial

— IPC  

Official title:

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03209128
• Other study ID #: IPC
• Status: Terminated
• Start date: April 20, 2017
• Est. completion date: March 19, 2021

Study information

• Verified date: June 2022
• Source: Centre Francois Baclesse, Luxembourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: March 19, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Radiation:
• Irradiation prophyllactique cérébrale
Irradiation prophyllactique cérébrale

Locations

Country	Name	City	State
Luxembourg	Centre Francois Baclesse	Esch Sur Alzette

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse, Luxembourg

Country where clinical trial is conducted

Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive function	Evaluate the cognitive function with Wechsler Memory Scale IV (WMS-IV) test	until 18 months after inclusion of patient
Secondary	Secondary effects according the CTCAE v.4 criteria	Evaluate the toxicity according the CTCAE v.4 criteria	until 18 months after inclusion of patient
Secondary	Appearance of brain metastases and their location	Evaluate the brain control with brain MRI	until 18 months after inclusion of patient
Secondary	Quality of life (QOL) of patients	Evaluate QOL with FACT-BR test (Functional Assessment of Cancer Therapy-Brain)	until 18 months after inclusion of patient