PET Response During Chemoradiation of Lung Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC

Conditions
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NSCLC

Intervention / Treatment
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* Other: Low dose FDG PET/CT 5 x.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low dose FDG PET/CT 5x<br>Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT). | Other: Low dose FDG PET/CT 5 x.<br>* 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.<br>* Other names: No treatment intervention but diagnostic intervention.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUVmax during the first two weeks of treatment, indicating inflammatory response. | • Increase SUVmax during the first two weeks of treatment, indicating inflammatory response. | 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. | Two weeks prior to treatment | 
| Progression free survival | • Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value. | 1 Year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, CCRT, FDG PET/CT