Pelvis Adaptive Radiotherapy (ART)

NCT ID: NCT06650033

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 280 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2031-11-30

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Adaptive radiotherapy +/- margin reduction

Intervention Type: 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.

Standard radiotherapy

Patients will receive standard image guided radiotherapy

Group Type: ACTIVE_COMPARATOR

Image guided radiotherapy

Intervention Type: RADIATION

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

Interventions

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.

Intervention Type: RADIATION

Image guided radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Age > 18

2. ECOG performance status 0-2

3. Patients receiving curative or adjuvant pelvic radiation including:

1. Prostate cancer where nodal treatment is required

2. Prostate cancer post prostatectomy

3. Bladder cancer

4. Rectal cancer

5. Anal cancer

6. Adjuvant radiotherapy for gynaecological cancers

7. Pelvic Lymph nodes only

4. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northern Sydney and Central Coast Area Health Service

OTHER

Sponsor Role: collaborator

Royal North Shore Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Kneebone

Role: PRINCIPAL_INVESTIGATOR

Northern Sydney Local Health District

Locations

Northern Sydney Local Health District

St Leonards, New South Wales, Australia

Countries

Australia

Central Contacts

Carol Kwong

Role: CONTACT

carolyn.kwong@health.nsw.gov.au

+61294631339

Heidi Tsang

Role: CONTACT

heidi.tsang@health.nsw.gov.au

+61294631340

Facility Contacts

Carol Kwong

Role: primary

carolyn.kwong@health.nsw.gov.au

+61294631339

Heidi Tsang

Role: backup

heidi.tsang@health.nsw.gov.au

+61294631340

Other Identifiers

Pelvis Adaptive Radiotherapy

Identifier Type: -

Identifier Source: org_study_id