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Pelvis Adaptive Radiotherapy (ART)

ConditionPelvis Neoplasms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRoyal North Shore Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age > 18

ECOG performance status 0-2

Prostate cancer where nodal treatment is required

Prostate cancer post prostatectomy

Disqualifiers

Hip prosthesis

Patient separation from approximate radiation centre to skin edge > 24cm, measured on diagnostic scan

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adaptive radiotherapy +/- margin reduction

    Radiation

    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 radiotherapy

    Radiation

    Standard radiation treatment used in the department of radiation oncology for cancer in pelvic area

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: Adaptive radiotherapy +/- margin reductionActive comparator 1 intervention
Group B: Standard radiotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months
4

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.

Time frame
Within 90 days of patients completing treatment

Secondary outcomes

1

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.

Time frame
Within 90 days of patients completing treatment
2

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.

Time frame
5 years
3

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.

Time frame
5 years
4

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.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Royal North Shore Hospital

Lead sponsor

Northern Sydney and Central Coast Area Health Service

Collaborator

Source ClinicalTrials.gov
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