No EGFR Activating Mutation Clinical Trial
— FLT-THERAOfficial 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 ?
| Verified date | February 2014 |
| Source | University Hospital, Angers |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | France: Ministry of Health |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 80 |
| Est. completion date | June 2016 |
| Est. primary completion date | June 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | University Hospital, Angers | Angers | Maine et Loire |
| France | University Hospital, Bordeaux | Bordeaux | Gironde |
| France | Hospital, Créteil | Créteil | Val de Marne |
| France | University Hospital, Nancy | Nancy | Meurthe et Moselle |
| France | Army Hospital, Percy | Percy | Haut de Seine |
| France | University Hospital, Rouen | Rouen | Seine maritime |
| France | University Hospital, Toulouse | Toulouse | Haute Garonne |
| France | University Hospital, Tours | Tours | Indre et Loire |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Angers | Army Hospital, Percy, Central Hospital, Nancy, France, Créteil Hospital, University Hospital, Bordeaux, University Hospital, Rouen, University Hospital, Toulouse, University Hospital, Tours |
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* Note: There are 38 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans | 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. | Six months | No |
| Secondary | Economic study of the early prediction of response to erlotinib therapy by 18F-FLT and 18F-FDG PETscans | The aim of this study will be to determine if health costs could be minimized by early prediction of response to erltinib therapy. | Six months | No |