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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04676828




Registration number
NCT04676828
Ethics application status
Date submitted
15/12/2020
Date registered
21/12/2020

Titles & IDs
Public title
Functional Lung Avoidance SPECT-guided Radiation Therapy of Lung Cancer
Scientific title
Functional Lung Avoidance SPECT-guided (ASPECT) Radiation Therapy for Lung Cancer Patients: Phase II Randomised Clinical Trial
Secondary ID [1] 0 0
KFE-1930
Universal Trial Number (UTN)
Trial acronym
ASPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Radiation-Induced Disorder 0 0
Radiation Pneumonitis 0 0
Pulmonary Disease 0 0
Lung Function Decreased 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Infection 0 0 0 0
Other infectious diseases
Infection 0 0 0 0
Studies of infection and infectious agents
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Single-photon-emission CT scan

Experimental: SPECT functional avoidance treatment - SPECT-based radiation therapy given taken functional distribution in the lung into account, that avoids highly functional lung volumes sparing them from radiation.

No intervention: Standard treatment - CT-based radiation therapy given over 5- 6.5 weeks.


Diagnosis / Prognosis: Single-photon-emission CT scan
SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung
Intervention code [1] 0 0
Diagnosis / Prognosis
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Radiation-induced lung toxicity
Timepoint [1] 0 0
Measured serially from 1 to 12 months after treatment completion
Secondary outcome [1] 0 0
Quality of life
Timepoint [1] 0 0
Measured serially from 1 to 12 months after treatment completion
Secondary outcome [2] 0 0
Patient reported lung symptoms
Timepoint [2] 0 0
Measured serially from 1 to 12 months after treatment completion
Secondary outcome [3] 0 0
Progression-free survival
Timepoint [3] 0 0
at 12 months
Secondary outcome [4] 0 0
Overall survival
Timepoint [4] 0 0
at 12 months
Secondary outcome [5] 0 0
Loco-regional control rate
Timepoint [5] 0 0
at 12 months

Eligibility
Key inclusion criteria
* histologically verified lung cancer (small-cell and non-small cell lung cancer)
* referred for radiotherapy with curative intent
* radiation dose of 60-66 Gy given in 2-Gy fractions, other dose levels and fractionation schedules accepted, as per site standard
* concurrent chemotherapy is accepted
* patients with oligometastatic disease are allowed, where metastasis have been ablated with surgery or radiotherapy
* receiving (chemo)-radiotherapy to the thoracic disease with curative intent
* adults over 18, that have given oral and written informed consent before patient registration.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* concurrent immunotherapy
* previous radiotherapy to the thorax
* other uncontrolled malignancies; any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
195
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Sydney West Radiation Oncology Network Westmead and Blacktown Hospitals - Sydney
Recruitment postcode(s) [1] 0 0
2145 - Sydney
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aarhus

Funding & Sponsors
Primary sponsor type
Other
Name
University of Aarhus
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Westmead and Blacktown Hospital, Sydney West Radiation Oncology Network, Sydney, Australia
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Aarhus University Hospital
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Katherina Farr, MD PhD
Address 0 0
Country 0 0
Phone 0 0
+4550303580
Fax 0 0
Email 0 0
[email protected]
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/NCT04676828