Pelvis NeoplasmsPelvis ARTNCT06650033
Pelvis Adaptive Radiotherapy (ART)
A study testing Adaptive radiotherapy +/- margin reduction and Image guided radiotherapy in people with Pelvis Neoplasms, run by Royal North Shore Hospital at 1 site in Australia.
Trial summary
Pelvis Adaptive radiotherapy (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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvis Neoplasms
- What is being tested?
- Adaptive radiotherapy +/- margin reduction and Image guided radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Oct 2025to 30 Nov 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- ECOG performance status 0-2
- Patients receiving curative or adjuvant pelvic radiation including:
- Prostate cancer where nodal treatment is required
- Prostate cancer post prostatectomy
- Bladder cancer
Show all 11Show fewer
- Rectal cancer
- Anal cancer
- Adjuvant radiotherapy for gynaecological cancers
- Pelvic Lymph nodes only
- Ability to understand and the willingness to sign an informed consent
Who cannot join
- Hip prosthesis
- Patient separation from approximate radiation centre to skin edge > 24cm, measured on diagnostic scan
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Northern Sydney Local Health District
St Leonards, New South Wales, 2065
Nada Cheikh-Ali, +61294631345, nada.cheikhali@health.nsw.gov.au
Heidi Tsang, +61294631340, heidi.tsang@health.nsw.gov.au
About this study
Official title: Pelvis Adaptive Radiation Therapy
Pelvis Adaptive radiotherapy (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.
Read the detailed description
Despite major technological advancements in the delivery of pelvic radiation therapy including the use of dynamic therapy, image guidance, integrated boosting and stereotactic techniques, toxicity from pelvic radiation remains a significant issue impacting on patient's quality of life and preventing the delivery of higher (and more curative) doses of radiation. Although evidence showed that adaptive radiotherapy demonstrating promising reduction of acute toxicity, the uptake of adaptive radiotherapy remains poor as adaptive radiation therapy is very labour intensive, time consuming and usually requires a radiation oncologist (RO) and Medical Physicist in attendance to review/modify target contours. These practices of daily multi-disciplinary team (MDT) in person attendance is not sustainable in the long term. Since 2021, Royal North Shore Hospital has been treating patients with cancer in the pelvic with Adaptive Radiation Therapy (ART) and Radiation Therapists (RT) at the site have undergone a rigorous University based Advanced Practitioner training programme. This study aims to evaluate RT-led ART in a randomised trial to assess the safety and feasibility of ART in a two stage phase 3 randomised controlled trial.
If this study can prove safety and feasibility in the first phase, it will proceed to the second phase of the study which will look at using adaptive radiotherapy to safely reduce CTV and PTV margins. The primary aim of the study will be to measure the difference in combined acute patient reported gastrointestinal (GI) and genitourinary (GU) toxicity between ART with margin reduction versus standard radiotherapy. Secondary aims will be to look at differences in clinician and patient reported acute and late GI and GU toxicity, disease free survival locoregional control, location of recurrence, the efficiency of ART including time taken per treatment, radiation dosimetric differences between the treatment arms and patients' perception of ART.
- Conditions
- Pelvis Neoplasms
- Being tested
- Adaptive radiotherapy +/- margin reduction, Image guided radiotherapy
- Medical subject headings
- Pelvic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive radiotherapy +/- margin reductionRadiation
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.
Image guided radiotherapyRadiation
Standard radiation treatment used in the department of radiation oncology for cancer in pelvic area
| Study group | Role | What they receive |
|---|---|---|
| Adaptive radiotherapy +/- margin reduction | Active comparator | 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. Receives: Radiation: Adaptive radiotherapy +/- margin reduction |
| Standard radiotherapy | Active comparator | Patients will receive standard image guided radiotherapy Receives: Radiation: Image guided radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose coverage of Clinical Target Volume (CTV) (% of CTV receiving 95% of prescribed dose) will be performed between the two arms (Safety).
The CTV dose coverage must be equal or better in 90% of fractions for 90% of patients in the adaptive arm will be 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). Percentage will be measured from 0-100%, a higher % is a better outcome.
Measured: 12 months
The percentage of organ at risk (OAR) dose volume histogram (DVH) metrics satisfying departmental protocol constraints will be compared for each patient between the two arms (Safety).
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 (safety). Percentage will be measured from 0-100%, a higher % is a better outcome.
Measured: 12 months
The percentage of successfully delivered fractions on the adaptive arm will be measured (feasibility).
At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study. Percentage will be measured from 0-100%, a higher % is a better outcome.
Measured: 12 months
Acute patient reported toxicity
The study will measure the difference in patient reported combined maximum genitourinGU and GI toxicity (Grade 2 or higher) as per PRO-CTCAE between the two treatment arms. PRO-CTCAE scale is generally measured from 0 to 5, higher scale being a worse outcome.
Measured: Within 90 days of patients completing treatment
Secondary outcomes (7)
Acute clinician reported toxicity
The study will measure the difference in acute combined maximum genitourinary (GU) and gastroenterology (GI) toxicity (Grade 2 or higher) grading between the two treatment arms as reported by clinicians using CTCAE v5.0. The CTCAE scale is generally measured from 0 to 5, higher scale being a worse outcome.
Measured: Within 90 days of patients completing treatment
Late clinician reported toxicity
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. The CTCAE scale is generally measured from 0 to 5, higher scale being a worse outcome.
Measured: 5 years
Late patient reported toxicity
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. The PRO-CTCAE scale is generally measured from 0 to 5, higher scale being a worse outcome.
Measured: 5 years
Disease free survival (DFS) (incorporating biochemical DFS for prostate cancer patients
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. DFS is measured as a continuous variable, a longer DFS is associated with better outcomes.
Measured: 5 years
Time differences between treatment arms
The study will assess the average absolute treatment time difference per fraction for adaptive radiation therapy compared to standard IGRT. Time is measured as a continuous variable, this is a descriptive statistic and longer or shorter time is not necessarily better or worse.
Measured: 5 years
Radiation dosimetric differences between treatment arms
The study will evaluate the radiation dosimetric differences between treatment using ART and treatment using standard IGRT.
Measured: 5 years
Patient reported attitudes and perceptions
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. Whether each perception is better or worse is dependent on the question.
Measured: 1 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start9 Oct 2025
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvis NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomised to Adaptive radiotherapy or standard radiotherapy, 2:1 randomisation
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal North Shore Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Responsible party
- Sponsor
- Investigators
- Andrew Kneebone, Principal investigator, Northern Sydney Local Health District
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06650033
- Sponsor's protocol ID
- Pelvis Adaptive Radiotherapy
- Acronym
- Pelvis ART
- Status last verified
- Feb 2026
- First submitted
- 17 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvis Adaptive Radiation Therapy
- ClinicalTrials.gov ID
- NCT06650033
- Acronym / sponsor ID
- Pelvis ART / Pelvis Adaptive Radiotherapy
- Conditions
- Pelvis Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Royal North Shore HospitalUniversity, hospital or other
- Collaborators
- Northern Sydney and Central Coast Area Health Service
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2031 (estimated)
- First posted
- 21 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pelvis Adaptive radiotherapy (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.
Detailed description
Despite major technological advancements in the delivery of pelvic radiation therapy including the use of dynamic therapy, image guidance, integrated boosting and stereotactic techniques, toxicity from pelvic radiation remains a significant issue impacting on patient's quality of life and preventing the delivery of higher (and more curative) doses of radiation. Although evidence showed that adaptive radiotherapy demonstrating promising reduction of acute toxicity, the uptake of adaptive radiotherapy remains poor as adaptive radiation therapy is very labour intensive, time consuming and usually requires a radiation oncologist (RO) and Medical Physicist in attendance to review/modify target contours. These practices of daily multi-disciplinary team (MDT) in person attendance is not sustainable in the long term. Since 2021, Royal North Shore Hospital has been treating patients with cancer in the pelvic with Adaptive Radiation Therapy (ART) and Radiation Therapists (RT) at the site have undergone a rigorous University based Advanced Practitioner training programme. This study aims to evaluate RT-led ART in a randomised trial to assess the safety and feasibility of ART in a two stage phase 3 randomised controlled trial.
If this study can prove safety and feasibility in the first phase, it will proceed to the second phase of the study which will look at using adaptive radiotherapy to safely reduce CTV and PTV margins. The primary aim of the study will be to measure the difference in combined acute patient reported gastrointestinal (GI) and genitourinary (GU) toxicity between ART with margin reduction versus standard radiotherapy. Secondary aims will be to look at differences in clinician and patient reported acute and late GI and GU toxicity, disease free survival locoregional control, location of recurrence, the efficiency of ART including time taken per treatment, radiation dosimetric differences between the treatment arms and patients' perception of ART.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomised to Adaptive radiotherapy or standard radiotherapy, 2:1 randomisation
| Arm | Type | Receives |
|---|---|---|
| Adaptive radiotherapy +/- margin reduction | Active comparator | Radiation: Adaptive radiotherapy +/- margin reductionPhase 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. |
| Standard radiotherapy | Active comparator | Radiation: Image guided radiotherapyPatients will receive standard image guided radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age > 18
- ECOG performance status 0-2
- Patients receiving curative or adjuvant pelvic radiation including:
- Ability to understand and the willingness to sign an informed consent
Key exclusion criteria (2 listed)
- Hip prosthesis
- Patient separation from approximate radiation centre to skin edge > 24cm, measured on diagnostic scan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive radiotherapy +/- margin reductionRadiotherapy 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. | Radiation | Adaptive radiotherapy +/- margin reduction |
| Image guided radiotherapyStandard radiation treatment used in the department of radiation oncology for cancer in pelvic area | Radiation | Standard radiotherapy |
Primary outcome
Dose coverage of Clinical Target Volume (CTV) (% of CTV receiving 95% of prescribed dose) will be performed between the two arms (Safety).
Time frame: 12 months
The CTV dose coverage must be equal or better in 90% of fractions for 90% of patients in the adaptive arm will be 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). Percentage will be measured from 0-100%, a higher % is a better outcome.
The percentage of organ at risk (OAR) dose volume histogram (DVH) metrics satisfying departmental protocol constraints will be compared for each patient between the two arms (Safety).
Time frame: 12 months
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 (safety). Percentage will be measured from 0-100%, a higher % is a better outcome.
The percentage of successfully delivered fractions on the adaptive arm will be measured (feasibility).
Time frame: 12 months
At least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study. Percentage will be measured from 0-100%, a higher % is a better outcome.
Acute patient reported toxicity
Time frame: Within 90 days of patients completing treatment
The study will measure the difference in patient reported combined maximum genitourinGU and GI toxicity (Grade 2 or higher) as per PRO-CTCAE between the two treatment arms. PRO-CTCAE scale is generally measured from 0 to 5, higher scale being a worse outcome.
7 secondary outcomes
Acute clinician reported toxicity
Time frame: Within 90 days of patients completing treatment
Late clinician reported toxicity
Time frame: 5 years
Late patient reported toxicity
Time frame: 5 years
Disease free survival (DFS) (incorporating biochemical DFS for prostate cancer patients
Time frame: 5 years
Time differences between treatment arms
Time frame: 5 years
Radiation dosimetric differences between treatment arms
Time frame: 5 years
Patient reported attitudes and perceptions
Time frame: 1 and 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Kneebone principal investigator
Northern Sydney Local Health District
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptive radiotherapy +/- margin reduction and Image guided radiotherapy in people with Pelvis Neoplasms, run by Royal North Shore Hospital at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nada Cheikh-Ali (+61294631345, nada.cheikhali@health.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose coverage of Clinical Target Volume (CTV) (% of CTV receiving 95% of prescribed dose) will be performed between the two arms (Safety). (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.