Non-small Cell Lung CancerPhase 2CALMETTENCT02507518
Role of PET Scan in the Evaluation of Early Response to Maintenance Treatment in Advanced Non-small-cell Lung Cancer
A Phase 2 study testing PET scan imaging in people with Non-small Cell Lung Cancer, run by Centre Henri Becquerel at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- PET scan imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesFrance
- Study dates
- Dec 2013to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
CHU Rouen-Hôpital Bois-Guillaume
Bois-Guillaume, 76230
Dominique Paillotin, MD, +33232889083, dominique.paillotin@chu-rouen.fr
- Recruiting
CH Dieppe
Dieppe, 76200
Julie Tillon, MD, +33232888031, julie.tillon@chu-rouen.fr
- Recruiting
Centre hospitalier intercommunal Elbeuf Louviers
Elbeuf, 76500
Pierre-Alexandre Hauss, MD, 02 32 82 21 45, pierre-alexandre.hauss@chi-elbeuf-louviers.fr
- Recruiting
Centre Henri Becquerel
Rouen, 76000
Stephanie Becker, MD, +33232082258, stephanie.becker@chb.unicancer.fr
- Recruiting
CHU Rouen
Rouen, 76000
Suzanna Bota, MD, +33232888287, suzanna.bota@chu-rouen.fr
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- PET scan imaging
- Keywords
- lung cancer, PET, progression free survival
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scan imagingProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Two Pet scan Imaging will be done : 14 days before and 16 days after the beginning of maintenance therapy Receives: Procedure: PET scan imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
time between the start of maintenance therapy and progression
Measured: 16 weeks after the start of maintenance therapy
Secondary outcomes (1)
progression free survival
time between the start of maintenance therapy and progression or death
Measured: on year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2015 (estimated)
- Study startDec 2013
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Becker, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02507518
- Sponsor's protocol ID
- CHB12.01
- Acronym
- CALMETTE
- Status last verified
- Jul 2018
- First submitted
- 21 Jul 2015
- Last updated
- 23 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02507518
- Acronym / sponsor ID
- CALMETTE / CHB12.01
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- lung cancer, PET, progression free survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 24 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Procedure: PET scan imagingTwo Pet scan Imaging will be done : 14 days before and 16 days after the beginning of maintenance therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scan imaginga 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 | Procedure or surgery | Experimental |
Primary outcome
progression free survival
Time frame: 16 weeks after the start of maintenance therapy
time between the start of maintenance therapy and progression
1 secondary outcome
progression free survival
Time frame: on year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Becker, MD principal investigator
Centre Henri Becquerel
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET scan imaging in people with Non-small Cell Lung Cancer, run by Centre Henri Becquerel at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie Becker, MD (+33232082258, stephanie.becker@chb.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression free survival (time frame: 16 weeks after the start of maintenance therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2018; AzTrials last refreshed its copy on 8 Nov 2026.