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Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer (CALMETTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Centre Henri Becquerel

Study Description
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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.


Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Procedure: PET scan imaging Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental
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


Outcome Measures
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Primary Outcome Measures :
  1. progression free survival [ Time Frame: 16 weeks after the start of maintenance therapy ]
    time between the start of maintenance therapy and progression


Secondary Outcome Measures :
  1. progression free survival [ Time Frame: on year ]
    time between the start of maintenance therapy and progression or death


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Stéphanie Becker, MD +33232082258 stephanie.becker@chb.unicancer.fr
Contact: Olivier Rastelli +33232082900 olivier.rastelli@chb.unicancer.fr

Locations
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France
CHU Rouen-Hôpital Bois-Guillaume Recruiting
Bois-Guillaume, France, 76230
Contact: Dominique Paillotin, MD    +33232889083    dominique.paillotin@chu-rouen.fr   
CH Dieppe Recruiting
Dieppe, France, 76200
Contact: Julie Tillon, MD    +33232888031    julie.tillon@chu-rouen.fr   
Centre hospitalier intercommunal Elbeuf Louviers Recruiting
Elbeuf, France, 76500
Contact: Pierre-Alexandre Hauss, MD    02 32 82 21 45    pierre-alexandre.hauss@chi-elbeuf-louviers.fr   
Centre Henri Becquerel Recruiting
Rouen, France, 76000
Contact: Stephanie Becker, MD    +33232082258    stephanie.becker@chb.unicancer.fr   
CHU Rouen Recruiting
Rouen, France, 76000
Contact: Suzanna Bota, MD    +33232888287    suzanna.bota@chu-rouen.fr   
Sponsors and Collaborators
Centre Henri Becquerel
Investigators
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Principal Investigator: Stéphanie Becker, MD Centre Henri Becquerel
More Information
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Responsible Party: Centre Henri Becquerel
ClinicalTrials.gov Identifier: NCT02507518    
Other Study ID Numbers: CHB12.01
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 23, 2018
Last Verified: July 2018
Keywords provided by Centre Henri Becquerel:
lung cancer, PET, progression free survival
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms