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.

PHASE3NOT_YET_RECRUITING

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.

info
Simpliy with AI

Study details:

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.

info
Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  • 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, Rectal cancer, Anal cancer, Adjuvant radiotherapy for gynaecological cancers, Pelvic Lymph nodes only
  • Ability to understand and the willingness to sign an informed consent
  • Exclusion criteria

  • Hip prosthesis
  • Patient separation from approximate radiation centre to skin edge > 24cm, measured on diagnostic scan
  • info
    Simplify with AI

    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2024-11-30

    Primary completion: 2029-11-30

    Study completion finish: 2031-11-30

    study type

    Study type

    TREATMENT

    phase

    Phase

      PHASE3

    trial

    Trial ID

    NCT06650033

    Intervention or treatment

    RADIATION: Adaptive radiotherapy +/- margin reduction

    RADIATION: Image guided radiotherapy

    Conditions

    • Pelvis Neoplasms
    Image related to Pelvis Neoplasms
    • Condition: Pelvis Neoplasms

    • RADIATION: Adaptive radiotherapy +/- margin reduction and other drugs

    • St Leonards, New South Wales, Australia

    • Sponsor: Royal North Shore Hospital

    Find a site

    Closest Location:

    Northern Sydney Local Health District

    Research sites nearby

    Select from list below to view details:

    • Northern Sydney Local Health District

      St Leonards, New South Wales, Australia

    Loading...

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    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.
    RADIATION: 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.
    ACTIVE_COMPARATOR: Standard radiotherapy
    • Patients will receive standard image guided radiotherapy
    RADIATION: Image guided radiotherapy
    • Standard radiation treatment used in the department of radiation oncology for cancer in pelvic area

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Safety of Adaptive Radiation Therapy via Radiation Therapists-led* treatment delivery (CTV coverage) A comparison of Clinical Target Volume (CTV) dose coverage will be performedThe 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).12 months
    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 performedThe 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.12 months
    Feasibility of ART via RT-led* treatment deliveryAt least 90% of patients must have 90% of planned adaptive treatments successfully delivered in phase 1 of the study.12 months
    Acute patient reported toxicityThe 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.Within 90 days of patients completing treatment

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Acute clinician reported toxicityThe 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.Within 90 days of patients completing treatment
    Late clinician reported toxicityThe 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 v5.05 years
    Late patient reported toxicityThe 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.5 years
    Disease free survival (DFS) (incorporating biochemical DFS for prostate cancer patientsThe 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 imaging5 years
    Time differences between treatment armsThe study will assess the average absolute treatment time difference per fraction for adaptive radiation therapy compared to standard IGRT5 years
    Radiation dosimetric differences between treatment armsThe study will evaluate the radiation dosimetric differences between treatment using ART and treatment using standard IGRT5 years
    Patient reported attitudes and perceptionsThe 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.1 and 5 years

    Frequently Asked Questions

    Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

    No questions submitted. Be the first to ask a question!

    You may be eligible to participate in this trial based on your search.Apply for study
    Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

    References

    Clinical Trials Gov: 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.

    Other trails to consider

    Top searched conditions