Dynamic FDG-PET/CT response during chemoradiation for NSCLC

Conditions: lung cancer
10029107

Registration Number: NL-OMON39496

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 42

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

• Age < 18 years
• Incapacitated subjects
• Pregnant or lactating women
• Diabetes Mellitus
• Participation in dose escalation studies
• Other neoplasms with metastases in the last 3 years

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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