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

Peter MacCallum Cancer Centre, Australia

Status

Completed

Conditions

Non Small Cell Lung Cancer Stage III

Treatments

Radiation: Functionally adapted, dose escalated VMAT radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT03569072

HREC/18/PMCC/23

U1111-1208-1546 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.