Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala (IPC)

June 20, 2022 updated by: Centre Francois Baclesse, Luxembourg

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)

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

11

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Luxembourg
      • Esch Sur Alzette, Luxembourg, 4005
        • Centre Francois Baclesse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Irradiation prophyllactique cérébrale
Radiation: Irradiation prophyllactique cérébrale
Irradiation prophyllactique cérébrale

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Francois Baclesse, Luxembourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 20, 2017

Primary Completion (Actual)

December 31, 2019

Study Completion (Actual)

March 19, 2021

Study Registration Dates

First Submitted

June 30, 2017

First Submitted That Met QC Criteria

July 3, 2017

First Posted (Actual)

July 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 23, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPC (Other Identifier: University of Maia)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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