18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy

Completed

• Conditions: NSCLC; Positron-Emission Tomography; Melanoma; Immunotherapy; 18F-FDG

• Registration Number: NCT03741231
• Lead Sponsor: University Hospital, Brest

Brief Summary

Study the EFS and OS according to 18FDG PET in patients with melanoma or non small cell lung cancer treated by immunotherapy.

Detailed Description

Study EFS in patients with melanoma or NSCLC treated by immunotherapy (anti CTLA4 or anti PDL1) and performed18FDG PET

Multicentric retrospective study

Study Timeline

• Study Start: 2018-03-01
• Primary Completion: 2018-06-30
• Study Completion: 2018-06-30
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-11-12
• Study First Posted: 2018-11-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• patients treated for melanoma or NSCLC with immunotherapy (anti CTLA4 or antiPDL1)
• patients treated in Brest, Morlaix, Landerneau hospital
• patients performed FDG PET
• no opposition to study

Exclusion Criteria

• age under 18 years old
• refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
measure of progression free survival (obtained by the delay between the date of initiation of immunotherapy until the date of first documented progression disease in patients with melanoma or NSCLC treated by immunotherapy	up to 50 months	From date of initiation of treatment until the date of first documented progression disease according to different criteria in interim PET/CT 1.; 18F-FDG PET/CT imaging was performed prior to (18F-FDG PET/CT 0) and 14 weeks after ICI onset (18F-FDG PET/CT 1). Assessment of patient response to treatment was done according to RECIST1.1, iRECIST, PERCIST and PECRIT criteria.

Secondary Outcome Measures

Name	Time	Method
Study different criteria (RECIST, iRECIST, PERCIST and PECRIT) to predict PFS or OS	up to 50 months	Interpretation according to 4 criteria to predict response to immunotherapy
study the potential correlation between PET data and clinicobiological data	up to 50 months	correlation between adverse events (AE) due to immunotherapy described on PET data and AE detected on clinicobiological data
measure of overall survival (obtained by the delay between the date of initiation of immunotherapy until the date of death related to disease in patients with melanoma or NSCLC treated by immunotherapy	up to 50 months	From date of initiation of treatment until the date of death related to disease according to different criteria in interim PET/CT 1.; 18F-FDG PET/CT imaging was performed prior to (18F-FDG PET/CT 0) and 14 weeks after ICI onset (18F-FDG PET/CT 1). Assessment of patient response to treatment was done according to RECIST1.1, iRECIST, PERCIST and PECRIT criteria.

Trial Locations

Locations (3)

CHRU de Brest; 🇫🇷 Brest, France

CH de LANDERNEAU; 🇫🇷 Landerneau, France

Centre Hospitalier de Morlaix; 🇫🇷 Morlaix, France