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Completed

NCT Number: NCT02315053

PET Response During Chemoradiation of Lung Cancer

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).

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Key information

Conditions

NSCLC

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Netherlands Cancer Institute

Amsterdam, North Holland, 1066CX, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: No treatment intervention but diagnostic intervention.

Primary outcomes

  1. maximum FDG uptake (SUVmax)

    Time frame: 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 outcomes

  1. SUVmax during the first two weeks of treatment, indicating inflammatory response.

    Time frame: First Two weeks of treatment

    • Increase SUVmax during the first two weeks of treatment, indicating inflammatory response.

  2. SUVmax in the two weeks prior to treatment, indicating progression

    Time frame: Two weeks prior to treatment

    • Increase SUVmax between diagnostic imaging and start of treatment, indicating potential progression.

  3. Progression free survival

    Time frame: 1 Year

    • Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2014
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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