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PET Response During Chemoradiation of Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE June 5, 2014
First Posted Date  ICMJE December 11, 2014
Last Update Posted Date October 27, 2017
Actual Study Start Date  ICMJE March 21, 2013
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2014)
  • 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.
  • 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.
  • Progression free survival [ Time Frame: 1 Year ]
    • Secondary study endpoint is progression free survival, to be associated with T50 for prognostic value.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PET Response During Chemoradiation of Lung Cancer
Official Title  ICMJE Dynamic FDG‐PET/CT Response During Chemoradiation for NSCLC
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).
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE NSCLC
Intervention  ICMJE 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.
Study Arms  ICMJE Low dose FDG PET/CT 5x
Stage II/III NSCLC will undergo a Low dose FDG PET/CT 5x during treatment (CCRT).
Intervention: Other: Low dose FDG PET/CT 5 x.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 26, 2017)
40
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2014)
42
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02315053
Other Study ID Numbers  ICMJE N12LPR
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The Netherlands Cancer Institute
Study Sponsor  ICMJE The Netherlands Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Wouter Vogel, MD,PhD NKI
PRS Account The Netherlands Cancer Institute
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP