Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-02-26 @ 7:29 AM
Study NCT ID:
NCT02507518
Status:
UNKNOWN
Last Update Posted:
2018-07-23
First Post:
2015-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer
Sponsor:
Centre Henri Becquerel
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2018-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CALMETTE
Brief Summary:
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.
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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: