Non Small Cell Lung Cancer Stage IIIHI-FIVENCT03569072
High Intensity Functional Image Guided Vmat Lung Evasion
A study testing Functionally adapted, dose escalated VMAT radiotherapy in people with Non Small Cell Lung Cancer Stage III, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer Stage III
- What is being tested?
- Functionally adapted, dose escalated VMAT radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jul 2018to 27 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Non Small Cell Lung Cancer Stage III
- Being tested
- Functionally adapted, dose escalated VMAT radiotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functionally adapted, dose escalated VMAT radiotherapyRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalated functionally adapted radiation therapy | Experimental | This is a single arm study Receives: Radiation: Functionally adapted, dose escalated VMAT radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (6)
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
Measured: 1 year
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.
Measured: 3 months and 12 months following completion of radiotherapy
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
Measured: 3 months and 12 months following completion of radiotherapy
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.
Measured: 3 months and 12 months following completion of radiotherapy
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.
Measured: 3 months and 12 months following completion of radiotherapy
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.
Measured: 3 months and 12 months following completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2018
- Primary completion27 Jan 2021
- Study completion27 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Non Small Cell Lung Cancer Stage IIIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicholas W Bucknell, MBBS (hons), Principal investigator, Peter Mac Callum Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569072
- Sponsor's protocol ID
- HREC/18/PMCC/23
- Other IDs
- U1111-1208-1546
- Acronym
- HI-FIVE
- Status last verified
- May 2022
- First submitted
- 30 May 2018
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gaudreault M, Korte J, Bucknell N, Jackson P, Sakyanun P, McIntosh L, Woon B, Buteau JP, Hofman MS, Mulcahy T, Kron T, Siva S, Hardcastle N. Comparison of dual-energy CT with positron emission tomography for lung perfusion imaging in patients with non-small cell lung cancer. Phys Med Biol. 2023 Jan 27;68(3). doi: 10.1088/1361-6560/acb198.
PubMed 36623318Bucknell N, Hardcastle N, Jackson P, Hofman M, Callahan J, Eu P, Iravani A, Lawrence R, Martin O, Bressel M, Woon B, Blyth B, MacManus M, Byrne K, Steinfort D, Kron T, Hanna G, Ball D, Siva S. Single-arm prospective interventional study assessing feasibility of using gallium-68 ventilation and perfusion PET/CT to avoid functional lung in patients with stage III non-small cell lung cancer. BMJ Open. 2020 Dec 10;10(12):e042465. doi: 10.1136/bmjopen-2020-042465.
PubMed 33303468
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Intensity Functional Image Guided Vmat Lung Evasion
- ClinicalTrials.gov ID
- NCT03569072
- Acronym / sponsor ID
- HI-FIVE / HREC/18/PMCC/23
- Conditions
- Non Small Cell Lung Cancer Stage III
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 27 Jan 2021 (actual)
- Study completion
- 27 Jan 2021 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose escalated functionally adapted radiation therapy | Experimental | Radiation: Functionally adapted, dose escalated VMAT radiotherapyThis is a single arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functionally adapted, dose escalated VMAT radiotherapyVolumetric 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. | Radiation | Dose escalated functionally adapted radiation therapy |
Primary outcome
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.
6 secondary outcomes
The number of patients with radiation pneumonitis will be assessed and graded using CTCAE v4.03
Time frame: 1 year
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
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
Quantitative voxel-wise comparison of CT Ventilation with Ventilation PET/CT
Time frame: 3 months and 12 months following completion of radiotherapy
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Derived from this study: PubMed 36623318Gaudreault M, Korte J, Bucknell N, Jackson P, Sakyanun P, McIntosh L, Woon B, Buteau JP, Hofman MS, Mulcahy T, Kron T, Siva S, Hardcastle N. Comparison of dual-energy CT with positron emission tomography for lung perfusion imaging in patients with non-small cell lung cancer. Phys Med Biol. 2023 Jan 27;68(3). doi: 10.1088/1361-6560/acb198.
- Derived from this study: PubMed 33303468Bucknell N, Hardcastle N, Jackson P, Hofman M, Callahan J, Eu P, Iravani A, Lawrence R, Martin O, Bressel M, Woon B, Blyth B, MacManus M, Byrne K, Steinfort D, Kron T, Hanna G, Ball D, Siva S. Single-arm prospective interventional study assessing feasibility of using gallium-68 ventilation and perfusion PET/CT to avoid functional lung in patients with stage III non-small cell lung cancer. BMJ Open. 2020 Dec 10;10(12):e042465. doi: 10.1136/bmjopen-2020-042465.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas W Bucknell, MBBS (hons) principal investigator
Peter Mac Callum Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functionally adapted, dose escalated VMAT radiotherapy in people with Non Small Cell Lung Cancer Stage III, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03569072, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.