Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose FDG PET/CT 5x | Other | Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose FDG PET/CT 5 x. | Other | 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. |
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Wouter Vogel, MD,PhD | NKI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Netherlands Cancer Institute | Amsterdam | North Holland | 1066CX | Netherlands |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
• 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 |