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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02588846




Registration number
NCT02588846
Ethics application status
Date submitted
14/07/2015
Date registered
28/10/2015

Titles & IDs
Public title
Multi-target Tracking in Prostate Radiotherapy Using MLC and KIM
Scientific title
Phase I Feasibility Study of Accounting for Relative Motion of Multiple Targets in Prostate Cancer Radiotherapy Using Realtime Multi-leaf Collimator Adaptation and Kilovoltage (kV) Intrafraction Monitoring
Secondary ID [1] 0 0
Multi-target tracking
Universal Trial Number (UTN)
Trial acronym
KOALA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'

Experimental: Stage 1: Optimise nodal treatment margin - During Stage 1: Optimise nodal treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. The nodal target position stability will be evaluated by the cone beam computed tomography (CBCT) imaging before and after each treatment session for the first 10 patients.

Experimental: Stage 2: Use treatment margin - During Stage 2: Use treatment margin, Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring' will be used to reshape the radiation beam in real-time. At the same time, multi-leaf collimator (MLC) tracking will be used to reshape the radiation beam in real-time using the margin size determined in Stage 1.


Treatment: Devices: Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'
This intervention uses the simultaneous combined use of two technologies: 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'. kV Intrafraction Monitoring (KIM) measures the motion of tissues targeted for radiotherapy in real time using kV imaging.The multi-leaf collimator (MLC) reshapes the radiation beam to maximise dose to the target tissue and minimise dose to the surrounding healthy tissue. Combining KIM and MLC allows the shaped radiation beam to follow the moving target (the prostate) while remaining fixed on a stationary target (lymph nodes) that are also being treated at the same time.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Software or mechanical failure
Timepoint [1] 0 0
The treatment period (2-9 weeks)
Secondary outcome [1] 0 0
Geometric accuracy
Timepoint [1] 0 0
The treatment period (2-9 weeks)
Secondary outcome [2] 0 0
Prostate motion trajectory
Timepoint [2] 0 0
Treatment period (2-9 weeks)
Secondary outcome [3] 0 0
Dosimetric accuracy
Timepoint [3] 0 0
Treatment period (2-9 weeks)
Secondary outcome [4] 0 0
Acute toxicity
Timepoint [4] 0 0
Treatment period (2-9 weeks) plus 3 months

Eligibility
Key inclusion criteria
* Patients undergoing definitive external beam radiotherapy at Northern Sydney Cancer Centre
* Patients histologically proven prostate adenocarcinoma
* PSA obtained within 3 months prior to enrolment
* Pelvic lymph nodes are included for treatment for patients at stage T1c-T3b with Gleason 8-10 or prostate-specific antigen (PSA) > 20 ng/ml or pelvic lymph node positivity on conventional imaging or prostate-specific membrane antigen (PSMA) scans.
* Patient must be able to have gold fiducial markers placed in the prostate
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Ability to understand and the willingness to sign a written informed consent document.
* Prostate dimension that allows leaf span with tracking margin of ±8mm
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients with artificial Hip(s), lumbar spinal surgical rods or other large metallic pelvic implants
* Patient's dimensions >40cm as measured at the level of the prostate
* Patients with overlapping implanted gold fiducials in x-ray imaging

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
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
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/07/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Thomas Eade, MBBS, RANZCR
Address 0 0
Director of Research, Senior Staff Specialist
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)?
Yes
What data in particular will be shared?
Share for research purposes with interested parties.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT02588846