Non Small Cell Lung Cancer Stage III
Conditions
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.
Interventions
RADIATIONFunctionally 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.
Sponsors
Peter MacCallum Cancer Centre, Australia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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% | 1 year | To assess the technical feasibility of the delivery of personalised functional lung radiotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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 |
| The number of patients with radiation pneumonitis will be assessed and graded using CTCAE v4.03 | 1 year | To determine the incidence of grade ≥ 2 clinical or radiological pneumonitis after high dose functionally adapted radiotherapy |
| Quantitative voxel-wise comparison of dual energy CT (DECT) iodine mapping with Perfusion PET/CT | 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. |
| The number of patients with Grade ≥ 2 cardiac toxicity will be assessed and graded using CTCAE v4.03. | 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. |
| Quantitative voxel-wise comparison of CT Ventilation with Ventilation PET/CT | 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. |
Countries
Australia
Outcome results
None listed