Cerebral Prophylactic Irradiation With Saving Hippocampus... | NCT03209128

Studies
Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala

NCT03209128

Sponsor

Centre Francois Baclesse, Luxembourg

Status

Terminated

Last Update Posted

Jun 23, 2022Actual

Enrollment

11Actual

Phase

Not provided

Conditions

Non Small Cell Lung Cancer

Interventions

Irradiation prophyllactique cérébrale

Countries

Luxembourg

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

diffciculties to recruit patients and a lot of patients prematurely terminated

Expanded Access Info

Start Date

Apr 20, 2017Actual

Primary Completion Date

Dec 31, 2019Actual

Completion Date

Mar 19, 2021Actual

First Submitted Date

Jun 30, 2017

First Submission Date that Met QC Criteria

Jul 3, 2017

First Posted Date

Jul 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2022

Last Update Posted Date

Jun 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Irradiation prophyllactique cérébrale			Radiation: Irradiation prophyllactique cérébrale

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Irradiation prophyllactique cérébrale	Radiation	Irradiation prophyllactique cérébrale	Irradiation prophyllactique cérébrale

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Secondary effects according the CTCAE v.4 criteria	Evaluate the toxicity according the CTCAE v.4 criteria	until 18 months after inclusion of patient
Appearance of brain metastases and their location

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with limited SCLC histologically proven to be responders or stable to radiochemotherapy or patients with histologically proven extended SCLC responding to chemotherapy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Francois Baclesse		Esch-sur-Alzette		4005	Luxembourg

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided