PET Response During Chemoradiation of Lung Cancer

Not Applicable

Completed

• Conditions: NSCLC
• Interventions: Other: Low dose FDG PET/CT 5 x.

• Registration Number: NCT02315053
• Lead Sponsor: The Netherlands Cancer Institute

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 Timeline

• Study Start: 2013-03-21
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-12-10
• Study First Posted: 2014-12-11
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low dose FDG PET/CT 5x	Low dose FDG PET/CT 5 x.	Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Progression free survival	1 Year	• Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.
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.

Trial Locations

Locations (1)

The Netherlands Cancer Institute; 🇳🇱 Amsterdam, Noord Holland, Netherlands