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Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy (SUPE_R)

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ClinicalTrials.gov Identifier: NCT03740126
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Novo Nordisk A/S
Danish Lung Cancer Group
Danish Comprehensive Cancer Center
Information provided by (Responsible Party):
Barbara Malene Fischer, Rigshospitalet, Denmark

Brief Summary:
The purpose of this study is to improve early detection of treatable relapse of lung cancer and thereby improve survival and quality of life for the patients. The investigators will perform a multicenter, randomized controlled trial to 1) assess if surveillance with whole body Positron Emission Tomography combined with Computer Tomography (PET/CT) including the brain can increase the number of treatable relapses and 2) concurrently collect liquid biopsies for later analysis, potentially enabling even earlier and minimally invasive detection and characterization of relapse.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Diagnostic Test: Whole body 18F-FDG PET/CT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 750 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Surveillance With PET/CT and Liquid Biopsies of Stage I-III Lung Cancer Patients After Completion of Definitive Therapy; a Randomized Controlled Trial
Actual Study Start Date : October 25, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy Lung Cancer

Arm Intervention/treatment
Experimental: Arm A, PET/CT
18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission tomography with computed tomography (FDG PET/CT) replacing computed tomography (CT) at months 6, 12, 18 and 24, otherwise as B with CT scan months 9, 15 and 21. Quality of life assessment and liquid biopsy every 3 months for later analysis.
Diagnostic Test: Whole body 18F-FDG PET/CT
In the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment. A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment. All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months.

No Intervention: Control arm B
CT-scan and clinical evaluation every 3 months. Quality of life assessment and liquid biopsy at every 3 months for later analysis.



Primary Outcome Measures :
  1. Number of relapses treatable with curative intent [ Time Frame: Until first detected relapse or 2 years after enrollment ]
    As decided by multidisciplinary meetings


Secondary Outcome Measures :
  1. Time to verified relapse [ Time Frame: From date of randomization until the date of first documented relapse assessed up to 24 months ]
    Relapse verified by histology or imaging combined with MDM review

  2. Overall survival [ Time Frame: From date of randomization until the date of censoring or death from any cause, whichever came first, assessed up to 36 months ]
    Death of any course or censoring

  3. Overall survival for patients with relapse [ Time Frame: From randomization until 12 months after first detected relapse or until death (whichever comes first) ]
    Death of any course or censoring

  4. Performance status at relapse [ Time Frame: From randomization until first detected relapse or 24 months ]
    Performance status of study participants at relapse will be assessed using Eastern Cooperative Oncology Group (ECOG) performance status scale from grade 0 to grade 4, where grade 0 corresponds to a patient who is "fully active, able to carry on all pre-disease performance without restriction" and grade 4 is a patient who is "completely disabled; cannot carry on any selfcare; totally confined to bed or chair".

  5. Quality of life / QLQ-C30 [ Time Frame: From randomization until first detected relapse or 24 months ]

    Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionaire Core Questionaire 30 (EORTC QLQ-C30).

    The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").


  6. Quality of life / QLQ-LC13 [ Time Frame: From randomization until first detected relapse or 24 months ]

    Quality of life will be assessed every 3rd month using a validated questionnaire, European Organisation for Research and Treatment of Cancer Quality of Life Questionair Lung Cancer 13 (EORTC QLQ-LC13).

    The questionaire is filled out by study participants at each control visit and patients score severity of a range of symptoms during the past week on a scale of 1 ("Not at all") to 4 ("Very much").


  7. Quality of life / Raw score [ Time Frame: From randomization until first detected relapse or 24 months ]
    From the results of QLQ-C30 and QLQ-LC13 a Raw Score (RS) is calculated (average of all scores) and Quality of Life is calculated as (RS - 1)/3 which outputs a value between 0 and 1, where 0 is a complete absence of symptoms and 1 is the maximum severity of all related symptoms. This will be used for calculation of QALY in the cost-effectiveness analysis.

  8. Number of procedures to assess incidental findings [ Time Frame: From randomization until 24 months or first detected relapse or until death (whichever comes first) ]
    Procedures resulting from an incidental finding on a follow up scan

  9. Types of procedures to assess incidental findings [ Time Frame: From randomization until 24 months or first detected relapse or until death (whichever comes first) ]
    Invasive / non-invasive

  10. Adverse events due to invasive procedures done to assess incidental findings [ Time Frame: From randomization until 24 months or first detected relapse or until death (whichever comes first) ]
    For example: Bleeding, pneumothorax, hospital admission

  11. Cost-effectiveness analysis of intervention [ Time Frame: From randomization until 24 months or 12 months after first detected relapse or until death (whichever comes first) ]
    Cost-effectiveness of the PET/CT regimen vs the CT regimen is assessed with the ICER (incremental cost-effectiveness ratio), i.e. the ratio of net health care costs to net QALYs ( quality-adjusted life years). Net health care costs are estimated as the health care costs difference between the two arms and net QALYs likewise. Health care costs are calculated from register-based information on health care consumption cumulated in 2-yrs follow-up (DRG-rates) supplemented by intervention costs based on project costs. The relevant cost data are available at "Sundhedsdatastyrelsen" using their research service.

  12. Type of treatment after verification of relapse [ Time Frame: From randomization until 12 months after first detected relapse or until death (whichever comes first) ]
    Description of treatment - e.g. surgical, radiotherapy, stereotactic ablative body radiotherapy, medical treatment



Information from the National Library of Medicine

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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:

  • Patient with non-small cell lung cancer (NSCLC), proven by cytology or histology
  • Patient in clinical stages I-III
  • Age≥ 18 years
  • Performance status ≤ 2 at the time of referral to therapy
  • Patient referred for definitive treatment (e.g. surgery, surgery followed by adjuvant chemotherapy, concomitant radio-chemotherapy, conventional or stereotactic radiotherapy or radiofrequency ablation).
  • Patient has given his/her written informed consent before any specific procedure from protocol

Exclusion Criteria:

  • Patient, whose disease has progressed within the first 3 months after cancer treatment, e.g. confirmed progressive disease on CT.
  • Persons deprived of liberty or under guardianship or curators
  • Dementia, mental alteration, severe psychiatric disease or other circumstances that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial
  • Pregnant or breastfeeding women
  • Patient participating in another interventional study during the surveillance period. This is only relevant for studies that might interfere with the intervention, whereas studies on late effects will not preclude participation in SUPE-R. Participation in protocols related only to initial treatment will not preclude participation in SUPE-R. Cases of doubt will be settled by the steering committee.

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): NCT03740126


Contacts
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Contact: Barbara M Fischer, MD PhD DMSci 0045 22266045 barbara.malene.fischer@regionh.dk
Contact: Kasper F Guldbrandsen, MD 0045 29277567 kasper.guldbrandsen@gmail.com

Locations
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Denmark
Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Mette Poehl, MD, PhD,       mette.poehl@regionh.dk   
Gentofte Hospital Recruiting
Gentofte, Denmark, 2900
Contact: Zaigham Sagir, MD PhD         
Herlev Hospital Recruiting
Herlev, Denmark, 2730
Contact: Kristin Skougaard, Ph.D    0045 38686515    Kristin.Skougaard@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Novo Nordisk A/S
Danish Lung Cancer Group
Danish Comprehensive Cancer Center
Investigators
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Principal Investigator: Barbara M Fischer, MD PhD DMSci Rigshospitalet, Denmark

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Responsible Party: Barbara Malene Fischer, Senior Consultant, Associate Professor, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03740126     History of Changes
Other Study ID Numbers: H-18009536
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Barbara Malene Fischer, Rigshospitalet, Denmark:
Positron Emission Tomography Computed Tomography
X-Ray Computed Tomography
Liquid Biopsy
Quality of Life
Medical Oncology
Radiation Oncology
Follow-up

Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases