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High Intensity Functional Image Guided Vmat Lung Evasion (HI-FIVE)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03569072
Recruitment Status : Recruiting
First Posted : June 26, 2018
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Peter MacCallum Cancer Centre, Australia

Brief Summary:

This study is being performed to assess the feasibility of adapting radiotherapy plans based on functional lung information and increasing the dose to the primary tumour. This is a single arm interventional pilot study involving 20 patients.

Aims Primary: to assess the feasibility of using ventilation and perfusion positron emission computed tomography (V/Q PET/CT) scans to adapt radiotherapy plans using Volumetric Modulated Arc Therapy (VMAT) to avoid regions of functional lung and deliver a higher dose to the primary tumour Secondary: to assess the incidence of acute and late radiotherapy toxicities, to quantify regional ventilation loss and regional perfusion loss on post treatment V/Q PET/CT, to assess associations of V/Q PET/CT with other functional lung imaging techniques, to assess overall survival, progression free survival and quality of life outcomes.

Participants: 20 patients stage IIIa-c non-small cell lung cancer for curative intent radiotherapy.

Methods: All patients will receive functional lung adapted 60 Gray (Gy) in 30 fractions to the primary and nodal planning target volume with a simultaneous integrated boost to the primary tumour to a total dose 69Gy in 30 fractions.

Expected outcomes: That functionally adapted lung radiotherapy using V/Q PET/CT imaging and VMAT planning is technically feasible.


Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Stage III Radiation: Functionally adapted, dose escalated VMAT radiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Functional Image Guided Vmat Lung Evasion
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose escalated functionally adapted radiation therapy
This is a single arm study
Radiation: Functionally adapted, dose escalated VMAT radiotherapy
Volumetric Modulated Arc Therapy planning and treatment delivery to treat primary and nodal planning target volume with 60 Gy in 30 fractions and a simultaneous integrated boost to the primary tumour to a total dose 69Gy in 30 fractions while avoiding organs at risk including functional lung, heart and oesophagus.




Primary Outcome Measures :
  1. Treatment will be considered feasible if all of the following criteria is met: Reduction in mean functional lung dose of ≥2%, functional lung volume receiving 20Gy of ≥4%, Mean heart dose is ≤30 Gy and relative heart volume receiving 50 Gy is <25% [ Time Frame: 1 year ]
    To assess the technical feasibility of the delivery of personalised functional lung radiotherapy.


Secondary Outcome Measures :
  1. The number of patients with radiation pneumonitis will be assessed and graded using CTCAE v4.03 [ Time Frame: 1 year ]
    To determine the incidence of grade ≥ 2 clinical or radiological pneumonitis after high dose functionally adapted radiotherapy

  2. Quantitative voxel-wise comparison of ventilation PET/CT measures will be contoured using semi-automatic threshold based on the operator's discretion and compared with the pre-treatment ventilation PET/CT. [ Time Frame: 3 months and 12 months following completion of radiotherapy ]
    To quantify regional ventilation loss on post treatment ventilation PET/CT following functionally adapted lung radiotherapy. Measures will use the end-inspiratory and end-expiratory volume for each lung and lobe. Assessed on V PET/CT imaging from baseline to 3 months post treatment and from baseline to 12 months.

  3. Quantitative voxel-wise comparison of perfusion PET/CT measures will be contoured using semi-automatic threshold based on the operator's discretion and compared with the pre-treatment perfusion PET/CT. [ Time Frame: 3 months and 12 months following completion of radiotherapy ]
    To quantify regional perfusion loss on post treatment ventilation PET/CT following functionally adapted lung radiotherapy. Measures will use the end-inspiratory and end-expiratory volume for each lung and lobe. Assessed on Q PET/CT imaging from baseline to 3 months post treatment and from baseline to 12 months

  4. Quantitative voxel-wise comparison of CT Ventilation with Ventilation PET/CT [ Time Frame: 3 months and 12 months following completion of radiotherapy ]
    To assess the associations between ventilation PET/CT with inhale/exhale CT ventilation. This will be compared on imaging at baseline, 3 months post treatment and 12 month post treatment.

  5. Quantitative voxel-wise comparison of dual energy CT (DECT) iodine mapping with Perfusion PET/CT [ Time Frame: 3 months and 12 months following completion of radiotherapy ]
    To assess the associations between perfusion PET/CT with dual energy CT iodine mapping ventilation (DECT iodine mapping is regarded as a surrogate for pulmonary perfusion). This will be compared on imaging at baseline, 3 months post treatment and 12 month post treatment.

  6. The number of patients with Grade ≥ 2 cardiac toxicity will be assessed and graded using CTCAE v4.03. [ Time Frame: 3 months and 12 months following completion of radiotherapy ]
    This will be assessed by pre, 3 and 12 month post treatment transthoracic echocardiograms and ECG investigations.



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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:

  • Age ≥ 18 years;
  • Written informed consent has been provided.
  • Histologically or cytologically confirmed Non-Small Cell Lung Cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 2 weeks prior to registration
  • Locally advanced disease (stage IIIA, IIIB, IIIC as per American Joint Committee on Cancer AJCC, 8th ed.) as confirmed on staging 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET/CT
  • No evidence of metastatic intracranial disease on CT brain with contrast or MRI
  • Willing to participate in the full follow up schedule
  • Planned for treatment with curative intent

Exclusion Criteria:

  • Participant is not able to tolerate supine position on PET/CT bed for the duration of the PET/CT acquisitions, is not cooperative, or needs continuous nursing (e.g. patient from Intensive Care Unit) or is unable to attend full course of follow up visits
  • Pregnancy or Breast-feeding
  • If history of a prior extra thoracic invasive malignancy (except non-melanomatous skin cancer) must be free from recurrence for a minimum of 3 years at the time of registration
  • Prior radiotherapy to the lungs or mediastinum (a history of prior breast radiotherapy is not an exclusion)
  • Prior known history of interstitial lung disease * A history of renal impairment or reaction to iodine contrast is not an exclusion criteria, if a patient has medical comorbidities that exclude the use of iodine contrasts, these exploratory investigations can be omitted.

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): NCT03569072


Contacts
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Contact: Nicholas W Bucknell, MBBS (hons) 61385595000 nick.bucknell@petermac.org

Locations
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Australia, Victoria
Peter MacCallum Cancer Centre Recruiting
Melbourne, Victoria, Australia, 3000
Contact: Nicholas W Bucknell, Dr    61385595000    nick.bucknell@petermac.org   
Contact: Shankar Siva, Associate Professor    61385595000    shankar.siva@petermac.org   
Principal Investigator: Nicholas W Bucknell, MBBS (hons)         
Sub-Investigator: Shankar Siva, MBBS, PhD         
Sponsors and Collaborators
Peter MacCallum Cancer Centre, Australia
Investigators
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Principal Investigator: Nicholas W Bucknell, MBBS (hons) Peter Mac Callum Cancer Centre
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Responsible Party: Peter MacCallum Cancer Centre, Australia
ClinicalTrials.gov Identifier: NCT03569072    
Other Study ID Numbers: HREC/18/PMCC/23
U1111-1208-1546 ( Registry Identifier: UTN )
First Posted: June 26, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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