Study Stopped
diffciculties to recruit patients and a lot of patients prematurely terminated
Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala
IPC
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)
1 other identifier
observational
11
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2017
CompletedFirst Submitted
Initial submission to the registry
June 30, 2017
CompletedFirst Posted
Study publicly available on registry
July 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 19, 2021
CompletedJune 23, 2022
June 1, 2022
2.7 years
June 30, 2017
June 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive function
Evaluate the cognitive function with Wechsler Memory Scale IV (WMS-IV) test
until 18 months after inclusion of patient
Secondary Outcomes (3)
Secondary effects according the CTCAE v.4 criteria
until 18 months after inclusion of patient
Appearance of brain metastases and their location
until 18 months after inclusion of patient
Quality of life (QOL) of patients
until 18 months after inclusion of patient
Study Arms (1)
Irradiation prophyllactique cérébrale
Interventions
Irradiation prophyllactique cérébrale
Eligibility Criteria
Patients with limited SCLC histologically proven to be responders or stable to radiochemotherapy or patients with histologically proven extended SCLC responding to chemotherapy
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Centre Francois Baclesse
Esch-sur-Alzette, 4005, Luxembourg
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 30, 2017
First Posted
July 6, 2017
Study Start
April 20, 2017
Primary Completion
December 31, 2019
Study Completion
March 19, 2021
Last Updated
June 23, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share