Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer
NCT ID: NCT02507518
Last Updated: 2018-07-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2013-12-31
2019-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Experimental
Two Pet scan Imaging will be done : 14 days before and 16 days after the beginning of maintenance therapy
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Henri Becquerel
OTHER
Responsible Party
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Principal Investigators
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Stéphanie Becker, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Henri Becquerel
Locations
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CHU Rouen-Hôpital Bois-Guillaume
Bois-Guillaume, , France
CH Dieppe
Dieppe, , France
Centre hospitalier intercommunal Elbeuf Louviers
Elbeuf, , France
Centre Henri Becquerel
Rouen, , France
CHU Rouen
Rouen, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHB12.01
Identifier Type: -
Identifier Source: org_study_id
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