Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer (CALMETTE)
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|ClinicalTrials.gov Identifier: NCT02507518|
Recruitment Status : Unknown
Verified July 2018 by Centre Henri Becquerel.
Recruitment status was: Recruiting
First Posted : July 24, 2015
Last Update Posted : July 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Procedure: PET scan imaging||Phase 2|
The purpose of the study is to optimize survival by an adapted metabolic imaging therapy in patients with advances non-small cell lung cancer.
The primary objective of the study is to evaluate the role of SUV and metabolic volume measured by FDG PETScan in the early prediction of treatment response.
80 patients will be included in 2 years. They will be follow up for one year for monitoring the progression free survival.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Role of 18FDG PET in the Evaluation of Early Response to Maintenance Treatment With Bevacizumab or Pemetrexed in Advanced Non-small-cell Lung Cancer|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||March 2019|
Two Pet scan Imaging will be done : 14 days before and 16 days after the beginning of maintenance therapy
Procedure: PET scan imaging
a PET scan will be done 2 weeks before the start of maintenance therapy and another 16 days after to predict the earlier response to treatment
- progression free survival [ Time Frame: 16 weeks after the start of maintenance therapy ]time between the start of maintenance therapy and progression
- progression free survival [ Time Frame: on year ]time between the start of maintenance therapy and progression or death
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): NCT02507518
|Contact: Stéphanie Becker, MDemail@example.com|
|Contact: Olivier Rastellifirstname.lastname@example.org|
|CHU Rouen-Hôpital Bois-Guillaume||Recruiting|
|Bois-Guillaume, France, 76230|
|Contact: Dominique Paillotin, MD +33232889083 email@example.com|
|Dieppe, France, 76200|
|Contact: Julie Tillon, MD +33232888031 firstname.lastname@example.org|
|Centre hospitalier intercommunal Elbeuf Louviers||Recruiting|
|Elbeuf, France, 76500|
|Contact: Pierre-Alexandre Hauss, MD 02 32 82 21 45 email@example.com|
|Centre Henri Becquerel||Recruiting|
|Rouen, France, 76000|
|Contact: Stephanie Becker, MD +33232082258 firstname.lastname@example.org|
|Rouen, France, 76000|
|Contact: Suzanna Bota, MD +33232888287 email@example.com|
|Principal Investigator:||Stéphanie Becker, MD||Centre Henri Becquerel|