Pelvis Adaptive Radiotherapy (ART)

NCT06650033 | Recruiting DMC

• 1 other identifier: Pelvis Adaptive Radiotherapy
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pelvis Neoplasms

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Within 90 days of patients completing treatment

Secondary Outcomes (7)

• Acute clinician reported toxicity

  Within 90 days of patients completing treatment

• Late clinician reported toxicity

  5 years

• Late patient reported toxicity

  5 years

• Disease free survival (DFS) (incorporating biochemical DFS for prostate cancer patients

  5 years

• Time differences between treatment arms

  5 years

Study Arms (2)

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.

Radiation: Adaptive radiotherapy +/- margin reduction

Standard radiotherapy

ACTIVE COMPARATOR

Patients will receive standard image guided radiotherapy

Radiation: Image guided radiotherapy

Interventions

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.

Adaptive radiotherapy +/- margin reduction

Image guided radiotherapy RADIATION

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

Standard radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Northern Sydney and Central Coast Area Health Service: collaborator
• Royal North Shore Hospital: lead

Study Sites (1)

Northern Sydney Local Health District

St Leonards, New South Wales, 2065, Australia

RECRUITING

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Radiotherapy, Image-Guided

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Andrew Kneebone

  Northern Sydney Local Health District

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada Cheikh-Ali

CONTACT

+61294631345; nada.cheikhali@health.nsw.gov.au

Heidi Tsang

CONTACT

+61294631340; heidi.tsang@health.nsw.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomised to Adaptive radiotherapy or standard radiotherapy, 2:1 randomisation

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 21, 2024
• Study Start: October 9, 2025
• Primary Completion (Estimated): November 30, 2029
• Study Completion (Estimated): November 30, 2031
• Last Updated: February 5, 2026

Record last verified: 2026-02

Locations

AU (1)