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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06650033




Registration number
NCT06650033
Ethics application status
Date submitted
17/10/2024
Date registered
21/10/2024
Date last updated
21/10/2024

Titles & IDs
Public title
Pelvis ART is a Two Phase Study Looking at Using Adaptive Radiotherapy to Help Reduce Toxicity for Cancer Patients Receiving Radiotherapy to the Pelvic Region. Adaptive Radiotherapy is a New Technology That Provides the Ability yo Account for Daily Changes in Anatomy.
Scientific title
Pelvis Adaptive Radiation Therapy
Secondary ID [1] 0 0
Pelvis Adaptive Radiotherapy
Universal Trial Number (UTN)
Trial acronym
Pelvis ART
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pelvis Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Adaptive radiotherapy +/- margin reduction
Treatment: Other - Image guided radiotherapy

Active comparator: Adaptive radiotherapy +/- margin reduction - Phase 1 and 2: Treating Radiation Therapists (RTs) on the treatment machine will review the treatment target and organs at risk contours that are automatically generated on the plan of the day. They will modify these safely, as required, and then also approve the computer generated re-plan of the day, within the bounds of departmental protocols and decision guides (RT led).

Phase 2 only: Margin reduction facilitated by adaptive radiotherapy.

Active comparator: Standard radiotherapy - Patients will receive standard image guided radiotherapy


Treatment: Other: Adaptive radiotherapy +/- margin reduction
Radiotherapy using adaptive technology to recontour and re-plan daily as required. Reductions in the PTV margin will also be introduced in the second phase of this study.

Treatment: Other: Image guided radiotherapy
Standard radiation treatment used in the department of radiation oncology for cancer in pelvic area
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage) A comparison of Clinical Target Volume (CTV) dose coverage will be performed
Assessment method [1] 0 0
The CTV dose coverage must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction. Dose coverage will be calculated as the percent of CTV receiving at least 95% of the prescribed dose (TD).
Timepoint [1] 0 0
12 months
Primary outcome [2] 0 0
Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (OAR DVH constraints) A comparison of organ at risk (OAR) dose-volume histogram (DVH) constraints will be performed
Assessment method [2] 0 0
The OAR DVH dose constraints must be equal or better in 90% of fractions for 90% of patients compared with the virtual image guided radiotherapy (IGRT) fraction.
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Feasibility of ART via RT-led* treatment delivery
Assessment method [3] 0 0
At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study.
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Acute patient reported toxicity
Assessment method [4] 0 0
The study will measure the difference in patient reported combined maximum GU and GI toxicity (Grade 2 or higher) as per PRO-CTCAE between the two treatment arms.
Timepoint [4] 0 0
Within 90 days of patients completing treatment
Secondary outcome [1] 0 0
Acute clinician reported toxicity
Assessment method [1] 0 0
The study will measure the difference in acute combined maximum GU and GI toxicity (Grade 2 or higher) grading between the two treatment arms as reported by clinicians using CTCAE v5.0.
Timepoint [1] 0 0
Within 90 days of patients completing treatment
Secondary outcome [2] 0 0
Late clinician reported toxicity
Assessment method [2] 0 0
The study will measure the difference in late GU and GI toxicity (Grade 2 or higher) between the two treatment arms as reported by clinicians using CTCAE v5.0
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Late patient reported toxicity
Assessment method [3] 0 0
The study will measure the difference in patient reported late GU and GI toxicity (Grade 2 or higher) between the two treatment arms as per PRO-CTCAE.
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Disease free survival (DFS) (incorporating biochemical DFS for prostate cancer patients
Assessment method [4] 0 0
The rate of disease free survival and the rate of biochemical failure in prostate cancer as defined as Nadir+2.0, commencement of ADT for relapse or evidence of disease recurrence on imaging
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Time differences between treatment arms
Assessment method [5] 0 0
The study will assess the average absolute treatment time difference per fraction for adaptive radiation therapy compared to standard IGRT
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Radiation dosimetric differences between treatment arms
Assessment method [6] 0 0
The study will evaluate the radiation dosimetric differences between treatment using ART and treatment using standard IGRT
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Patient reported attitudes and perceptions
Assessment method [7] 0 0
The study will assess the patient experience with radiotherapy on a five item questionnaire that uses a five-point Likert-scale (ranging from strongly disagree to strongly agree). Differences in responses for each question between the arms will be reported.
Timepoint [7] 0 0
1 and 5 years

Eligibility
Key inclusion criteria
1. Age > 18
2. ECOG performance status 0-2
3. Patients receiving curative or adjuvant pelvic radiation including:

1. Prostate cancer where nodal treatment is required
2. Prostate cancer post prostatectomy
3. Bladder cancer
4. Rectal cancer
5. Anal cancer
6. Adjuvant radiotherapy for gynaecological cancers
7. Pelvic Lymph nodes only
4. Ability to understand and the willingness to sign an informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hip prosthesis
* Patient separation from approximate radiation centre to skin edge > 24cm, measured on diagnostic scan

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/11/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/11/2031
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Sydney Local Health District - St Leonards
Recruitment postcode(s) [1] 0 0
2065 - St Leonards

Funding & Sponsors
Primary sponsor type
Other
Name
Royal North Shore Hospital
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northern Sydney and Central Coast Area Health Service
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Kneebone
Address 0 0
Northern Sydney Local Health District
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carol Kwong
Address 0 0
Country 0 0
Phone 0 0
+61294631339
Email 0 0
carolyn.kwong@health.nsw.gov.au
Contact person for scientific queries

No information has been provided regarding IPD availability


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/NCT06650033