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PET Response During Chemoradiation of Lung Cancer

NCT ID: NCT02315053

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-21

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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NSCLC

Keywords

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NSCLC CCRT FDG PET/CT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Low dose FDG PET/CT 5x

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

Group Type OTHER

Low dose FDG PET/CT 5 x.

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Other Intervention Names

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No treatment intervention but diagnostic intervention.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Netherlands Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wouter Vogel, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

NKI

Locations

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The Netherlands Cancer Institute

Amsterdam, North Holland, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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N12LPR

Identifier Type: -

Identifier Source: org_study_id