NSCLC
Conditions
Keywords
NSCLC, CCRT, FDG PET/CT
Brief 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).
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.
Interventions
OTHERLow dose FDG PET/CT 5 x.
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.
Sponsors
The Netherlands Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum FDG uptake (SUVmax) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SUVmax during the first two weeks of treatment, indicating inflammatory response. | First Two weeks of treatment | • Increase SUVmax during the first two weeks of treatment, indicating inflammatory response. |
| SUVmax in the two weeks prior to treatment, indicating progression | Two weeks prior to treatment | • Increase SUVmax between diagnostic imaging and start of treatment, indicating potential progression. |
| Progression free survival | 1 Year | • Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value. |
Countries
Netherlands
Outcome results
None listed