NCT03569072

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 27, 2021

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

2.6 years

First QC Date

May 30, 2018

Last Update Submit

May 17, 2022

Conditions

Non Small Cell Lung Cancer Stage III

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (6)

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

    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.

    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.

    3 months and 12 months following completion of radiotherapy

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

    3 months and 12 months following completion of 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

  • +1 more secondary outcomes

Study Arms (1)

Dose escalated functionally adapted radiation therapy

EXPERIMENTAL

This is a single arm study

Radiation: Functionally adapted, dose escalated VMAT radiotherapy

Interventions

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.

Dose escalated functionally adapted radiation therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

Related Publications (2)

  • 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.

    PMID: 36623318DERIVED

  • Bucknell 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.

    PMID: 33303468DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Nicholas W Bucknell, MBBS (hons)

    Peter Mac Callum Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2018

First Posted

June 26, 2018

Study Start

July 1, 2018

Primary Completion

January 27, 2021

Study Completion

January 27, 2021

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)