Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient (FLT-THERA)
|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: NCT02069418|
Recruitment Status : Unknown
Verified February 2014 by University Hospital, Angers.
Recruitment status was: Active, not recruiting
First Posted : February 24, 2014
Last Update Posted : February 24, 2014
In France, lung cancer is the leading cause of death induced by cancer. Therapeutic advances have been made in therapy of unresectable non-small cell lung cancer (NSCLC) with tyrosine kinase receptor inhibitors blocking the Epidermal Growth Factor Receptor (EGFR), as erlotinib.
This drug usually does not induce rapid shrinking of NSCLC tumour explaining why RECIST criteria are less reliable with erlotinib than cytotoxic drugs after 8 weeks of treatment.
Among patients with unresectable NSCLC, 3'-deoxy-3'-18F-fluoro-L-thymidine (18F-FLT) and 18F-2-18F-fluoro-2-deoxy-D-glucose (18F- FDG) Positron Emission Tomography (PET) has identified early responding patients and with better progression-free survival in erlotinib first line and in the second or third line.
To date, none medico-economic study has been conducted to determine if this strategy will be cost-effective.
The purpose of this study is to confirm that an early metabolic imaging with 18 F-FLT and 18FFDG PET could have theranostic issue by identifying at the fourteenth day of erlotinib (second line or more) the subjects that do not respond to erlotinib, i.e. 6 weeks prior to the morphological evaluation based on the new RECIST 1.1, that is typically done at week 8 of erlotinib treatment.
A health economics ancillary study will be achieved. Indeed, recent therapeutic improvements, in particular targeted therapies in NSCLC, have improved quality of life and life expectancy, but have also induce an important increase of the health costs. According to studies, the mean cost of the treatments of NSCLC has been increased by a factor 3 during the 10 last years. More efficient strategies that would permit to stop early with objective endpoints, expensive therapies is a main achievement in thoracic oncology.
The potential clinical impacts of this work are 1) to stop early erlotinib in non-responders and replace another treatment before a deterioration in their physical status, 2) reduce the risk of side effects and costs of unnecessary treatment and 3) to propose a customization treatment after the first line therapy.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent No EGFR Activating Mutation||Radiation: 18F-FLT-TEP Radiation: 18F-FDG-TEP||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Could Positon Emission Tomography With Radiolabelled 3'-Deoxy-3'-(18)F-Fluoro-L-Thymidine be a Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patients ?|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||June 2016|
Experimental: Experimental arm
All patients will be in the same arm. Patients are going to have two 18F-FLT-TEP and two 18F-FDG-TEP : the first ones during the two weeks before the beginning of erlotinib and the second ones will occur during the second week after the initiation of erlotinib. The order of TEP is not definite : 18F-FLT-TEP may be planned first or reciprocally. A period of 48 hours must separate two TEP.
Patients are going to have two 18F-FLT-TEP : one during the two weeks before the beginning of erlotinib and the second one will occur during the second week after the initiation of erlotinib.
Patients are going to have two 18F-FDG-TEP : one during the two weeks before the beginning of erlotinib and the second one will occur during the second week after the initiation of erlotinib.
- Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans [ Time Frame: Six months ]The primary endpoint is the correlation between tumour response to erlotinib assessed by morphological imaging by RECIST 1.1 at Day 56 (considered the gold standard) and the change in the uptake of 18F-FLT and 18F-FDG assessed by PET before and at Day 7 after initiation of erlotinib derived from criteria PERCIST. the Kappa test will be used.
- Economic study of the early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans [ Time Frame: Six months ]The aim of this study will be to determine if health costs could be minimized by early prediction of response to erltinib therapy.
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): NCT02069418
|University Hospital, Bordeaux|
|Bordeaux, Gironde, France, 33000|
|Army Hospital, Percy|
|Percy, Haut de Seine, France, 92140|
|University Hospital, Toulouse|
|Toulouse, Haute Garonne, France, 31000|
|University Hospital, Tours|
|Tours, Indre et Loire, France, 37000|
|University Hospital, Angers|
|Angers, Maine et Loire, France, 49933|
|University Hospital, Nancy|
|Nancy, Meurthe et Moselle, France, 54000|
|University Hospital, Rouen|
|Rouen, Seine maritime, France, 76000|
|Créteil, Val de Marne, France, 94000|
|Principal Investigator:||José HUREAUX, MD, PhD||University Hospital, Angers|
|Study Chair:||Olivier COUTURIER, MD, PhD||University Hospital, Angers|