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PET Response During Chemoradiation of Lung Cancer

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ClinicalTrials.gov Identifier: NCT02315053
Recruitment Status : Completed
First Posted : December 11, 2014
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
The Netherlands Cancer Institute

Study Description
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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).

Condition or disease Intervention/treatment Phase
NSCLC Other: Low dose FDG PET/CT 5 x. Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dynamic FDG-PET/CT Response During Chemoradiation for NSCLC
Actual Study Start Date : March 21, 2013
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

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Arms and Interventions
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Arm Intervention/treatment
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 Name: No treatment intervention but diagnostic intervention.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315053


Locations
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Netherlands
The Netherlands Cancer Institute
Amsterdam, Noord Holland, Netherlands, 1066CX
Sponsors and Collaborators
The Netherlands Cancer Institute
Investigators
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Principal Investigator: Wouter Vogel, MD,PhD NKI
More Information
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Responsible Party: The Netherlands Cancer Institute
ClinicalTrials.gov Identifier: NCT02315053    
Other Study ID Numbers: N12LPR
First Posted: December 11, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The Netherlands Cancer Institute:
NSCLC
CCRT
FDG PET/CT