Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- maximum FDG uptake (SUVmax)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Low dose FDG PET/CT 5x
Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT).
Intervention: Low dose FDG PET/CT 5 x. (Other)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- SUVmax during the first two weeks of treatment, indicating inflammatory response.(First Two weeks of treatment)
- Progression free survival(1 Year)
- SUVmax in the two weeks prior to treatment, indicating progression(Two weeks prior to treatment)