Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer (CALMETTE)
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
PET scan imaging
Sponsored by
About this trial
This is an interventional other trial for Non-small Cell Lung Cancer focused on measuring lung cancer, PET, progression free survival
Eligibility Criteria
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
Exclusion Criteria:
- 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
Sites / Locations
- CHU Rouen-Hôpital Bois-GuillaumeRecruiting
- CH DieppeRecruiting
- Centre hospitalier intercommunal Elbeuf LouviersRecruiting
- Centre Henri BecquerelRecruiting
- CHU RouenRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental
Arm Description
Two Pet scan Imaging will be done : 14 days before and 16 days after the beginning of maintenance therapy
Outcomes
Primary Outcome Measures
progression free survival
time between the start of maintenance therapy and progression
Secondary Outcome Measures
progression free survival
time between the start of maintenance therapy and progression or death
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02507518
Brief Title
Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer
Acronym
CALMETTE
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 Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
March 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Henri Becquerel
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
lung cancer, PET, progression free survival
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Two Pet scan Imaging will be done : 14 days before and 16 days after the beginning of maintenance therapy
Intervention Type
Procedure
Intervention Name(s)
PET scan imaging
Intervention Description
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
Primary Outcome Measure Information:
Title
progression free survival
Description
time between the start of maintenance therapy and progression
Time Frame
16 weeks after the start of maintenance therapy
Secondary Outcome Measure Information:
Title
progression free survival
Description
time between the start of maintenance therapy and progression or death
Time Frame
on year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie Becker, MD
Phone
+33232082258
Email
stephanie.becker@chb.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivier Rastelli
Phone
+33232082900
Email
olivier.rastelli@chb.unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie Becker, MD
Organizational Affiliation
Centre Henri Becquerel
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rouen-Hôpital Bois-Guillaume
City
Bois-Guillaume
ZIP/Postal Code
76230
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dominique Paillotin, MD
Phone
+33232889083
Email
dominique.paillotin@chu-rouen.fr
Facility Name
CH Dieppe
City
Dieppe
ZIP/Postal Code
76200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Tillon, MD
Phone
+33232888031
Email
julie.tillon@chu-rouen.fr
Facility Name
Centre hospitalier intercommunal Elbeuf Louviers
City
Elbeuf
ZIP/Postal Code
76500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Alexandre Hauss, MD
Phone
02 32 82 21 45
Email
pierre-alexandre.hauss@chi-elbeuf-louviers.fr
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Becker, MD
Phone
+33232082258
Email
stephanie.becker@chb.unicancer.fr
Facility Name
CHU Rouen
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suzanna Bota, MD
Phone
+33232888287
Email
suzanna.bota@chu-rouen.fr
12. IPD Sharing Statement
Learn more about this trial
Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer
We'll reach out to this number within 24 hrs