NSCLCNCT02315053
PET Response During Chemoradiation of Lung Cancer
A study testing Low dose FDG PET/CT 5 x. in people with NSCLC, run by The Netherlands Cancer Institute at 1 site in Netherlands.
Trial summary
A prospective observational study to determine the prognostic value of the timing of 50% reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- NSCLC
- What is being tested?
- Low dose FDG PET/CT 5 x.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 21 Mar 2013to Sep 2017
- Phase
- Interventional
- 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
- Cytologically or histologically proven NSCLC
- T2-4 N0-3 M0 disease (stage II or III, inoperable)
- Scheduled for standard concurrent chemoradiation
- Primary tumour minimal diameter 3 cm
- Primary tumour SUVmax > 5 on routine diagnostic pre-treatment FDG (Fludeoxyglucose) PET/CT
- WHO performance 0-1
- Written informed consent according to GCP (Good Clinical Practice) and national regulations
Who cannot join
- Age < 18 years, incapacitated subjects
- Pregnant or lactating women
- Diabetes mellitus requiring medication
- Participation in dose escalation studies
- Other neoplasms in the last 3 years, with metastases
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
The Netherlands Cancer Institute
Amsterdam, North Holland, 1066CX
About this study
Official title: Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC
A prospective observational study to determine the prognostic value of the timing of 50% reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).
Read the detailed description
This is a single-centre observational study. Patients with proven locally advanced NSCLC will be treated with concurrent chemoradiotherapy according to the standard clinical protocol of the NKI-AVL. During treatment, the biological behaviour of the tumour will be monitored with serial quantitative FDG (fluorodeoxyglucose) PET/CT scans. From these images, the time during treatment where a 50% reduction in FDG uptake relative to day 1 is reached (T50) will be derived. The T50 of progression-free surviving patients will be compared with that of relapsed or deceased patients, in order to find a value that predicts early treatment failure. An additional FDG PET/CT scan at the same day as regular follow up CT scan will be made, two months after treatment, to have a baseline after treatment for follow up.
- Conditions
- NSCLC
- Being tested
- Low dose FDG PET/CT 5 x.
- Keywords
- NSCLC, CCRT, FDG PET/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose FDG PET/CT 5 x.Other
Also called No treatment intervention but diagnostic intervention.
Multiple FDG PET/CT studies will be added to the normal diagnostic procedures as a part of this study, with the number of scans depending on the study stage, to a maximum of 6 per patient.
| Study group | Role | What they receive |
|---|---|---|
| Low dose FDG PET/CT 5x | Other | Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT). Receives: Other: Low dose FDG PET/CT 5 x. |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum FDG uptake (SUVmax)
- A main study parameter is the maximum FDG uptake (SUVmax (maximum Standardized Uptake Value)) at the location of the primary tumour, as determined at multiple days during treatment (with a maximum of five time points per patient), expressed as T50 for response evaluation.
Measured: 1 Year
Secondary outcomes (3)
SUVmax during the first two weeks of treatment, indicating inflammatory response.
- Increase SUVmax during the first two weeks of treatment, indicating inflammatory response.
Measured: First Two weeks of treatment
SUVmax in the two weeks prior to treatment, indicating progression
- Increase SUVmax between diagnostic imaging and start of treatment, indicating potential progression.
Measured: Two weeks prior to treatment
Progression free survival
- Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2014 (estimated)
- Study start21 Mar 2013
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NSCLCStudies of the same condition, open and under way.
- More trials run by The Netherlands Cancer InstituteThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Netherlands Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wouter Vogel, MD,PhD, Principal investigator, NKI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02315053
- Sponsor's protocol ID
- N12LPR
- Status last verified
- Oct 2017
- First submitted
- 5 Jun 2014
- Last updated
- 27 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC
- ClinicalTrials.gov ID
- NCT02315053
- Acronym / sponsor ID
- N12LPR
- Conditions
- NSCLC
- Keywords
- NSCLC, CCRT, FDG PET/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- The Netherlands Cancer InstituteUniversity, hospital or other
- Study start
- 21 Mar 2013 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Dec 2014 (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.
A prospective observational study to determine the prognostic value of the timing of 50% reduction in metabolic activity (T50) during CCRT for NSCLC for treatment outcome (PFS).
Detailed description
This is a single-centre observational study. Patients with proven locally advanced NSCLC will be treated with concurrent chemoradiotherapy according to the standard clinical protocol of the NKI-AVL. During treatment, the biological behaviour of the tumour will be monitored with serial quantitative FDG (fluorodeoxyglucose) PET/CT scans. From these images, the time during treatment where a 50% reduction in FDG uptake relative to day 1 is reached (T50) will be derived. The T50 of progression-free surviving patients will be compared with that of relapsed or deceased patients, in order to find a value that predicts early treatment failure. An additional FDG PET/CT scan at the same day as regular follow up CT scan will be made, two months after treatment, to have a baseline after treatment for follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low dose FDG PET/CT 5x | Other | Other: Low dose FDG PET/CT 5 x.Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Cytologically or histologically proven NSCLC
- T2-4 N0-3 M0 disease (stage II or III, inoperable)
- Scheduled for standard concurrent chemoradiation
- Primary tumour minimal diameter 3 cm
- Primary tumour SUVmax > 5 on routine diagnostic pre-treatment FDG (Fludeoxyglucose) PET/CT
Key exclusion criteria (5 listed)
- Age < 18 years, incapacitated subjects
- Pregnant or lactating women
- Diabetes mellitus requiring medication
- Participation in dose escalation studies
- Other neoplasms in the last 3 years, with metastases
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 |
|---|---|---|
| Low dose FDG PET/CT 5 x.Also: No treatment intervention but diagnostic intervention.Multiple FDG PET/CT studies will be added to the normal diagnostic procedures as a part of this study, with the number of scans depending on the study stage, to a maximum of 6 per patient. | Other | Low dose FDG PET/CT 5x |
Primary outcome
maximum FDG uptake (SUVmax)
Time frame: 1 Year
• A main study parameter is the maximum FDG uptake (SUVmax (maximum Standardized Uptake Value)) at the location of the primary tumour, as determined at multiple days during treatment (with a maximum of five time points per patient), expressed as T50 for response evaluation.
3 secondary outcomes
SUVmax during the first two weeks of treatment, indicating inflammatory response.
Time frame: First Two weeks of treatment
SUVmax in the two weeks prior to treatment, indicating progression
Time frame: Two weeks prior to treatment
Progression free survival
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2017.
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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.
Wouter Vogel, MD,PhD principal investigator
NKI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose FDG PET/CT 5 x. in people with NSCLC, run by The Netherlands Cancer Institute at 1 site in Netherlands.
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 5 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: finished, as of the sponsor's last update on 27 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maximum FDG uptake (SUVmax) (time frame: 1 Year). 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 27 Oct 2017.