Theranostic Tool During Erlotinib Treatment in Non-small Cell Lung Cancer Patient (FLT-THERA)

February 19, 2014 updated by: University Hospital, Angers

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 ?

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Gironde
      • Bordeaux, Gironde, France, 33000
        • University Hospital, Bordeaux
    • Haut de Seine
      • Percy, Haut de Seine, France, 92140
        • Army Hospital, Percy
    • Haute Garonne
      • Toulouse, Haute Garonne, France, 31000
        • University Hospital, Toulouse
    • Indre et Loire
      • Tours, Indre et Loire, France, 37000
        • University Hospital, Tours
    • Maine et Loire
      • Angers, Maine et Loire, France, 49933
        • University Hospital, Angers
    • Meurthe et Moselle
      • Nancy, Meurthe et Moselle, France, 54000
        • University Hospital, Nancy
    • Seine maritime
      • Rouen, Seine maritime, France, 76000
        • University Hospital, Rouen
    • Val de Marne
      • Créteil, Val de Marne, France, 94000
        • Hospital, Créteil

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: José HUREAUX, MD, PhD, University Hospital, Angers
  • Study Chair: Olivier COUTURIER, MD, PhD, University Hospital, Angers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 19, 2014

First Posted (Estimate)

February 24, 2014

Study Record Updates

Last Update Posted (Estimate)

February 24, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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