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Completed

NCT Number: NCT03569072

High Intensity Functional Image Guided Vmat Lung Evasion

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.

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Key information

Conditions

Non Small Cell Lung Cancer Stage III Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functionally adapted, dose escalated VMAT radiotherapy

Radiation

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Registry information

Acronym: HI-FIVE

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 26, 2018
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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