PET Response During Chemoradiation of Lung Cancer

NSCLC Clinical Trial

Official title:

Dynamic FDG‐PET/CT Response During Chemoradiation for NSCLC

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315053
• Other study ID #: N12LPR
• Status: Completed
• Phase: N/A
• First received: June 5, 2014
• Last updated: October 26, 2017
• Start date: March 21, 2013
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• NSCLC

Intervention

Other:
• Low dose FDG PET/CT 5 x.
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.

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam	Noord Holland

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	SUVmax in the two weeks prior to treatment, indicating progression	• Increase SUVmax between diagnostic imaging and start of treatment, indicating potential progression.	Two weeks prior to treatment
Secondary	Progression free survival	• Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.	1 Year