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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03569072




Registration number
NCT03569072
Ethics application status
Date submitted
30/05/2018
Date registered
26/06/2018

Titles & IDs
Public title
High Intensity Functional Image Guided Vmat Lung Evasion
Scientific title
High Intensity Functional Image Guided Vmat Lung Evasion
Secondary ID [1] 0 0
U1111-1208-1546
Secondary ID [2] 0 0
HREC/18/PMCC/23
Universal Trial Number (UTN)
Trial acronym
HI-FIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer Stage III 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Functionally adapted, dose escalated VMAT radiotherapy

Experimental: Dose escalated functionally adapted radiation therapy - This is a single arm study


Treatment: Other: 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 code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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%
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
The number of patients with radiation pneumonitis will be assessed and graded using CTCAE v4.03
Timepoint [1] 0 0
1 year
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
3 months and 12 months following completion of radiotherapy
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
3 months and 12 months following completion of radiotherapy
Secondary outcome [4] 0 0
Quantitative voxel-wise comparison of CT Ventilation with Ventilation PET/CT
Timepoint [4] 0 0
3 months and 12 months following completion of radiotherapy
Secondary outcome [5] 0 0
Quantitative voxel-wise comparison of dual energy CT (DECT) iodine mapping with Perfusion PET/CT
Timepoint [5] 0 0
3 months and 12 months following completion of radiotherapy
Secondary outcome [6] 0 0
The number of patients with Grade = 2 cardiac toxicity will be assessed and graded using CTCAE v4.03.
Timepoint [6] 0 0
3 months and 12 months following completion of radiotherapy

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/01/2021
Sample size
Target
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Nicholas W Bucknell, MBBS (hons)
Address 0 0
Peter Mac Callum Cancer Centre
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03569072