High Intensity Functional Image Guided Vmat Lung Evasion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-01-27

Brief Summary

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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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Detailed Description

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Conditions

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Non Small Cell Lung Cancer Stage III

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose escalated functionally adapted radiation therapy

This is a single arm study

Group Type EXPERIMENTAL

Functionally adapted, dose escalated VMAT radiotherapy

Intervention Type 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.

Interventions

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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.

Intervention Type RADIATION

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No