Clinical trial NCT02069418: Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer Metastatic or Non-small Cell Lung Cancer Recurrent
No EGFR Activating Mutation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital, Tours
name: Army Hospital, Percy
name: Créteil Hospital
name: University Hospital, Rouen
name: Central Hospital, Nancy, France
name: University Hospital, Toulouse
name: University Hospital, Bordeaux
First posted: 2014-02-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* age over superior to 18
* NSCLC proved by a histological biopsy
* EGFR mutation status known with no activating EGFR mutation
* indication of erlotinib therapy after at least one previous therapy
* patients who have signed an informed consent to participate in this study
* life expectancy exceeding 12 weeks
* WHO activity score between 0 and 2.

Exclusion Criteria:

* contraindication for the initiation of erlotinib
* refusal to sign the consent
* progressive inflammatory disease
* infection with the HIV virus
* other malignant disease
* life expectancy less than 12 weeks
* major adults protected by French law

Primary outcomes:
measure: Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans
timeFrame: Six months
Secondary outcomes:
measure: Economic study of the early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans
timeFrame: Six months
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
state: Gironde
city: Percy
country: France
facility: Army Hospital, Percy
state: Haut de Seine
city: Toulouse
country: France
facility: University Hospital, Toulouse
state: Haute Garonne
city: Tours
country: France
facility: University Hospital, Tours
state: Indre et Loire
city: Angers
country: France
facility: University Hospital, Angers
state: Maine et Loire
city: Nancy
country: France
facility: University Hospital, Nancy
state: Meurthe et Moselle
city: Rouen
country: France
facility: University Hospital, Rouen
state: Seine maritime
city: Créteil
country: France
facility: Hospital, Créteil
state: Val de Marne
Study officials:
affiliation: University Hospital, Angers
name: José HUREAUX, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital, Angers
name: Olivier COUTURIER, MD, PhD
role: STUDY_CHAIR
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