PET Response During Chemoradiation of Lung Cancer

NCT02315053 | Completed

• 1 other identifier: N12LPR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

NSCLC

Keywords

NSCLC; CCRT; FDG PET/CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

  Two weeks prior to treatment

• Progression free survival

  1 Year

Study Arms (1)

Low dose FDG PET/CT 5x

OTHER

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

Other: Low dose FDG PET/CT 5 x.

Interventions

Low dose FDG PET/CT 5 x. OTHER

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.

Also known as: No treatment intervention but diagnostic intervention.

Low dose FDG PET/CT 5x

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead

Study Sites (1)

The Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

Location

Study Officials

• Wouter Vogel, MD,PhD

  NKI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: December 11, 2014
• Study Start: March 21, 2013
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 27, 2017

Record last verified: 2017-10

Locations

NL (1)