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Cerebral Prophylactic Irradiation With Saving Hippocampus and Amygdala (IPC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209128
Recruitment Status : Unknown
Verified August 2018 by Centre Francois Baclesse, Luxembourg.
Recruitment status was:  Recruiting
First Posted : July 6, 2017
Last Update Posted : August 17, 2018
Sponsor:
Information provided by (Responsible Party):
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


Condition or disease Intervention/treatment
Non Small Cell Lung Cancer Radiation: Irradiation prophyllactique cérébrale

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Cognitive function [ Time Frame: until 18 months after inclusion of patient ]
    Evaluate the cognitive function with Wechsler Memory Scale IV (WMS-IV) test


Secondary Outcome Measures :
  1. 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

  2. Appearance of brain metastases and their location [ Time Frame: until 18 months after inclusion of patient ]
    Evaluate the brain control with brain MRI

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209128


Contacts
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Contact: Bérangère Frédérick, MD 00352571167200 berangere.frederick@baclesse.lu
Contact: Charlotte Lieunard 00352571167200 charlotte.lieunard@baclesse.lu

Locations
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Luxembourg
Centre Francois Baclesse Recruiting
Esch Sur Alzette, Luxembourg, 4005
Sponsors and Collaborators
Centre Francois Baclesse, Luxembourg
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Responsible Party: Centre Francois Baclesse, Luxembourg
ClinicalTrials.gov Identifier: NCT03209128    
Other Study ID Numbers: IPC
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: August 17, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases