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

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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
Sponsor:
Collaborators:
University Hospital, Tours
Army Hospital, Percy
Créteil Hospital
University Hospital, Rouen
Central Hospital, Nancy, France
University Hospital, Toulouse
University Hospital, Bordeaux
Information provided by (Responsible Party):
University Hospital, Angers

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.


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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.
Radiation: 18F-FLT-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.

Radiation: 18F-FDG-TEP
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
France
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
Hospital, Créteil
Créteil, Val de Marne, France, 94000
Sponsors and Collaborators
University Hospital, Angers
University Hospital, Tours
Army Hospital, Percy
Créteil Hospital
University Hospital, Rouen
Central Hospital, Nancy, France
University Hospital, Toulouse
University Hospital, Bordeaux
Investigators
Principal Investigator: José HUREAUX, MD, PhD University Hospital, Angers
Study Chair: Olivier COUTURIER, MD, PhD University Hospital, Angers

Publications:
Aouba A, Pequignot F, Le Toullec A, Jougla E. Les causes médicales de décès en France en 2004 et leur évolution 1980-2004. Bul Epidémiol Hebd 2007;35-36:308-14.
Rosell R, Carcereny E, Gervais R, Vergnenegre A, Massuti B, Felip E, Palmero R, Garcia-Gomez R, Pallares C, Sanchez JM, Porta R, Cobo M, Garrido P, Longo F, Moran T, Insa A, De Marinis F, Corre R, Bover I, Illiano A, Dansin E, de Castro J, Milella M, Reguart N, Altavilla G, Jimenez U, Provencio M, Moreno MA, Terrasa J, Muñoz-Langa J, Valdivia J, Isla D, Domine M, Molinier O, Mazieres J, Baize N, Garcia-Campelo R, Robinet G, Rodriguez-Abreu D, Lopez-Vivanco G, Gebbia V, Ferrera-Delgado L, Bombaron P, Bernabe R, Bearz A, Artal A, Cortesi E, Rolfo C, Sanchez-Ronco M, Drozdowskyj A, Queralt C, de Aguirre I, Ramirez JL, Sanchez JJ, Molina MA, Taron M, Paz-Ares L; Spanish Lung Cancer Group in collaboration with Groupe Français de Pneumo-Cancérologie and Associazione Italiana Oncologia Toracica. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised phase 3 trial. Lancet Oncol. 2012 Mar;13(3):239-46. doi: 10.1016/S1470-2045(11)70393-X. Epub 2012 Jan 26.

Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02069418     History of Changes
Other Study ID Numbers: PHRC 2012-01
2013-001301-87 ( EudraCT Number )
First Posted: February 24, 2014    Key Record Dates
Last Update Posted: February 24, 2014
Last Verified: February 2014

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Fluorodeoxyglucose F18
Alovudine
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals
Antiviral Agents
Anti-Infective Agents