High Intensity Functional Image Guided Vmat Lung Evasion - Clinical Trial for Non Small Cell Lung Cancer Stage III | NCT03569072

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Primary Purpose

Status

Completed

Phase

Not Applicable

Locations

Australia

Study Type

Interventional

Intervention

Functionally adapted, dose escalated VMAT radiotherapy

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer Stage III

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Peter MacCallum Cancer Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dose escalated functionally adapted radiation therapy

Arm Description

This is a single arm study

Outcomes

Primary Outcome Measures

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%

To assess the technical feasibility of the delivery of personalised functional lung radiotherapy.

Secondary Outcome Measures

The number of patients with radiation pneumonitis will be assessed and graded using CTCAE v4.03

To determine the incidence of grade ≥ 2 clinical or radiological pneumonitis after high dose functionally adapted radiotherapy

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.

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.

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

Quantitative voxel-wise comparison of CT Ventilation with Ventilation PET/CT

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.

Quantitative voxel-wise comparison of dual energy CT (DECT) iodine mapping with Perfusion PET/CT

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.

This will be assessed by pre, 3 and 12 month post treatment transthoracic echocardiograms and ECG investigations.

Full Information

NCT ID

NCT03569072

First Posted

May 30, 2018

Last Updated

May 17, 2022

Sponsor

Peter MacCallum Cancer Centre, Australia

1. Study Identification

Unique Protocol Identification Number

NCT03569072

Brief Title

High Intensity Functional Image Guided Vmat Lung Evasion

Acronym

HI-FIVE

Official Title

High Intensity Functional Image Guided Vmat Lung Evasion

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

January 27, 2021 (Actual)

Study Completion Date

January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peter MacCallum Cancer Centre, Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer Stage III

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose escalated functionally adapted radiation therapy

Arm Type

Experimental

Arm Description

This is a single arm study

Intervention Type

Radiation

Intervention Name(s)

Functionally adapted, dose escalated VMAT radiotherapy

Intervention Description

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 Measure Information:

Title

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%

Description

To assess the technical feasibility of the delivery of personalised functional lung radiotherapy.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

The number of patients with radiation pneumonitis will be assessed and graded using CTCAE v4.03

Description

To determine the incidence of grade ≥ 2 clinical or radiological pneumonitis after high dose functionally adapted radiotherapy

Time Frame

1 year

Title

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.

Description

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.

Time Frame