Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03209128
Other study ID # IPC
Secondary ID
Status Terminated
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05094804 - A Study of OR2805, a Monoclonal Antibody Targeting CD163, Alone and in Combination With Anticancer Agents Phase 1/Phase 2
Recruiting NCT05707286 - Pilot Study to Determine Pro-Inflammatory Cytokine Kinetics During Immune Checkpoint Inhibitor Therapy
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Completed NCT01945021 - Phase II Safety and Efficacy Study of Crizotinib in East Asian Patients With ROS1 Positive, ALK Negative Advanced NSCLC Phase 2
Completed NCT04487457 - Prospective Study to Evaluate the Blood Kinetics of Immune Cells and Immunosuppressive Cytokines After Exposure to an Immunity Checkpoint Inhibitor (ICI): Study of the Impact of Chemotherapy
Terminated NCT04022876 - A Study of ALRN-6924 for the Prevention of Chemotherapy-induced Side Effects (Chemoprotection) Phase 1
Recruiting NCT05898763 - TEIPP Immunotherapy in Patients With NSCLC Phase 1/Phase 2
Recruiting NCT05532696 - Phase 1b/2 Study to Evaluate ABT-101 in Solid Tumor and NSCLC Patients Phase 1/Phase 2
Completed NCT04311034 - A Study of RC48-ADC in Subjects With Advanced Non-small Cell Lung Cancer Phase 1/Phase 2
Active, not recruiting NCT03177291 - Pirfenidone Combined With Standard First-Line Chemotherapy in Advanced-Stage Lung NSCLC Phase 1
Terminated NCT03257722 - Pembrolizumab + Idelalisib for Lung Cancer Study Phase 1/Phase 2
Completed NCT00349089 - Trial on Refinement of Early Stage Lung Cancer Adjuvant Therapy Phase 2
Completed NCT05116891 - A Phase 1/2 Study of CAN04 in Combination With Different Chemotherapy Regimens in Subjects With Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT04571632 - Clinical Trial of SBRT and Systemic Pembrolizumab With or Without Avelumab/Ipilimumab+ Dendritic Cells in Solid Tumors Phase 2
Terminated NCT03599518 - DS-1205c With Gefitinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer Phase 1
Not yet recruiting NCT06020989 - Lazertinib and Chemotherapy Combination in EGFR-mutant NSCLC Patients Without ctDNA Clearance After lead-in Lazertinib Monotherapy Phase 2
Withdrawn NCT03982134 - PDR001 + Panobinostat for Melanoma and NSCLC Phase 1
Withdrawn NCT03574649 - QUILT-2.024: Phase 2 Neoadjuvant, Consolidation, and Adjuvant Combination NANT Immunotherapy Versus Standard of Care in Subjects With Resectable Non-small Cell Lung Cancer Phase 2
Withdrawn NCT02844140 - DE-CT in Lung Cancer Proton Therapy N/A
Terminated NCT02628535 - Safety Study of MGD009 in B7-H3-expressing Tumors Phase 1