NCT Number: NCT06650033
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
St Leonards, New South Wales, 2065, Australia
Location status: Recruiting
George Hruby
SUB_INVESTIGATOR
Heidi Tsang
CONTACT
Joseph Chan
SUB_INVESTIGATOR
Nada Cheikh-Ali
CONTACT
Sarah Bergamin
SUB_INVESTIGATOR
Thomas Eade
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Standard radiation treatment used in the department of radiation oncology for cancer in pelvic area
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.
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.
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.
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.
Time frame: Within 90 days of patients completing treatment
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
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.
Time frame: 5 years
The study will evaluate the radiation dosimetric differences between treatment using ART and treatment using standard IGRT.
Time frame: 1 and 5 years
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.
Contact information is provided by the study sponsor or research team.
Heidi Tsang
CONTACT
Nada Cheikh-Ali
CONTACT
Royal North Shore Hospital
Other
Pelvis Adaptive Radiation Therapy
Acronym: Pelvis ART
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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