Dynamic FDG-PET/CT response during chemoradiation for NSCLC

Dynamic FDG-PET/CT response during chemoradiation for NSCLC - PET response during chemoradiation of lung cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON39496

Enrollment

Registered

2012-11-21

Start date

2012-10-01

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 PET/CT • WHO performance 0-1 • Written informed consent according to GCP and national regulations

Exclusion criteria

Exclusion criteria: • Age

Design outcomes

Primary

Measure	Time frame
• The main study parameter is the maximum FDG uptake (SUVmax) at the location of the primary tumour, as determined at multiple days during treatment (up to five time points per patient), expressed as T50 for response evaluation. • The main study endpoint is progression free survival, to be correlated with T50 for prognostic value.	—

Secondary

Measure	Time frame
Secondary study parameters/endpoints • Increase SUVmax during de first two weeks of treatment, indicating inflammatory response. • Increase SUVmax between diagnostic imaging and day 1, indicating potential progression. Other study parameters Available image sets will be evaluated using several other diagnostic methods. This will not contribute to the main study outcome, but may yield interesting additional knowledge and potential new strategies for outcome prediction. • Anatomical response based on RECIST criteria. • Biological response based on EORTC criteria. • Alternative T50 based on SUVmean of the primary tumour. • Alternative T50 based on SUVpeak of the primary tumour. • Alternative T50 based on SUVmax/mean of nodal metastases in the imaging range. • Voxel-based evaluation to identify intra-tumoural differences in response.	—

Measure

Time frame

Secondary study parameters/endpoints • Increase SUVmax during de first two weeks of treatment, indicating inflammatory response. • Increase SUVmax between diagnostic imaging and day 1, indicating potential progression. Other study parameters Available image sets will be evaluated using several other diagnostic methods. This will not contribute to the main study outcome, but may yield interesting additional knowledge and potential new strategies for outcome prediction. • Anatomical response based on RECIST criteria. • Biological response based on EORTC criteria. • Alternative T50 based on SUVmean of the primary tumour. • Alternative T50 based on SUVpeak of the primary tumour. • Alternative T50 based on SUVmax/mean of nodal metastases in the imaging range. • Voxel-based evaluation to identify intra-tumoural differences in response.

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Countries

Netherlands

Outcome results