PET Response During Chemoradiation of Lung Cancer

Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC

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).

Study Overview

• Status: Completed
• Conditions: NSCLC
• Intervention / Treatment: Other: Low dose FDG PET/CT 5 x.

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord Holland
    • Amsterdam, Noord Holland, Netherlands, 1066CX
      • The Netherlands Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Low dose FDG PET/CT 5x; Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT).	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.; Other Names: No treatment intervention but diagnostic intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Progression free survival	• Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.	1 Year

Collaborators and Investigators

• Sponsor: The Netherlands Cancer Institute
• Investigators: Principal Investigator: Wouter Vogel, MD,PhD, NKI

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2013
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: June 5, 2014
• First Submitted That Met QC Criteria: December 10, 2014
• First Posted (Estimate): December 11, 2014

Study Record Updates

• Last Update Posted (Actual): October 27, 2017
• Last Update Submitted That Met QC Criteria: October 26, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: NSCLC; FDG PET/CT; CCRT
• Other Study ID Numbers: N12LPR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No