Informations générales (source: ClinicalTrials.gov)
Role of 18FDG PET in the Evaluation of Early Response to Maintenance Treatment With Bevacizumab or Pemetrexed in Advanced Non-small-cell Lung Cancer (CALMETTE)
Interventional
Phase 2
Centre Henri Becquerel (Voir sur ClinicalTrials)
décembre 2013
mars 2019
29 juin 2024
Non small cell lung cancer is the first cause of cancer related death in France and is
becoming an increasing health problem in developing countries.
Recently for patient with no progression disease after first line chemotherapy, new
therapies were validated in maintenance (bevacizumab) or switch maintenance treatment
(erlotinib, pemetrexed) with improved survival.
Until now, determination of efficiency of treatment is only based on morphological
response (RECIST) and remains inappropriate to such cytostatic drugs for which there is
no anatomical lesion modification.
Nuclear Medicine and especially 18-FDG Positron Emission Tomography (PET) offers a
biologically relevant tool for assessment of tumour response therapies.
The assumption of the study is that FDG PET would allow to earlier detect a lack of
response, thereafter, to modify an ineffective treatment. Indeed, nowadays the treatment
is maintained up to evidence of progression disease.
However, despite the increasing use of FDG PET for predicting therapeutic response, there
are no validated criteria for judging response of maintenance therapy in non-small cell
lung cancer.
It seems necessary to determine standardized criteria response, earlier during the course
of maintenance therapy in patient with non small cell lung cancer.
The final aim is to optimize survival by an adapted metabolic imaging guided therapy.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Henri Becquerel - 76000 - Rouen - France | Stephanie Becker, MD | Contact (sur clinicalTrials) | |||
| CH Dieppe - 76200 - Dieppe - France | Julie Tillon, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen - 76000 - Rouen - France | Suzanna Bota, MD | Contact (sur clinicalTrials) | |||
| CHU Rouen-Hôpital Bois-Guillaume - 76230 - Bois-Guillaume - France | Dominique Paillotin, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre hospitalier intercommunal Elbeuf Louviers - 76500 - Elbeuf - France | Pierre-Alexandre Hauss, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age superior to 18 years old
- Effective contraception method or negative pregnancy test at the inclusion
- OMS inferior or equal to 1
- Non-small cell lung cancer stage IIIb or IV
- Non progressive disease after at lest 4 cycles of platinum-based chemotherapy
- Eligible fo maintenance therapy with bevacizumab and/or pemetrexed
- Inform consent signed
- Age superior to 18 years old
- Effective contraception method or negative pregnancy test at the inclusion
- OMS inferior or equal to 1
- Non-small cell lung cancer stage IIIb or IV
- Non progressive disease after at lest 4 cycles of platinum-based chemotherapy
- Eligible fo maintenance therapy with bevacizumab and/or pemetrexed
- Inform consent signed
- Evolution of a second cancer in the 3 years before inclusion
- Pregnancy or breast-feeding
- poorly controlled diabetes
- curatorship or guardianship
- contraindication to iodinated contrast agents
- participation to another clinical research with an experimental drug
- impossible decubitus
- not possibility to follow-up the procedures of the study due to geographic, social
or psychic reasons