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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
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
Timepoint [2] 0 0
12 months
Primary outcome [3] 0 0
Feasibility of ART via RT-led* treatment delivery
Timepoint [3] 0 0
12 months
Primary outcome [4] 0 0
Acute patient reported toxicity
Timepoint [4] 0 0
Within 90 days of patients completing treatment
Secondary outcome [1] 0 0
Acute clinician reported toxicity
Timepoint [1] 0 0
Within 90 days of patients completing treatment
Secondary outcome [2] 0 0
Late clinician reported toxicity
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Late patient reported toxicity
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Disease free survival (DFS) (incorporating biochemical DFS for prostate cancer patients
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Time differences between treatment arms
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Radiation dosimetric differences between treatment arms
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Patient reported attitudes and perceptions
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
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Northern Sydney and Central Coast Area Health Service
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Pelvis ART is a two phase study looking at using adaptive radiotherapy to help reduce toxicity for cancer patients having radiotherapy in the pelvic region.

Adaptive radiotherapy is a new technology that provides the ability to account for daily changes in anatomy. Adaptive radiotherapy also provides a foundation for which radiotherapy margins might be safely reduced.

Phase 1 of this study is looking to see if a radiation therapist centred adaptive workflow can be implemented. If phase 1 of this study is safe and feasible, the study will proceed to phase 2. Phase 2 of the study looks at using adaptive technology to reduce radiation treatment margins. The primary aim of this study is to see whether margin reduced treatment using adaptive radiotherapy can reduce side effects for patients with cancer in the pelvic area.
Trial website
https://clinicaltrials.gov/study/NCT06650033
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Andrew Kneebone
Address 0 0
Northern Sydney Local Health District
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06650033