Adaptive radiotherapy for pelvic cancers

Pelvis Adaptive Radiation Therapy

This trial will test whether radiation therapist–led adaptive radiotherapy, including smaller treatment margins, can reduce side effects for adults getting curative or adjuvant pelvic radiotherapy.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Royal North Shore Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (St Leonards, New South Wales)
• Trial ID: NCT06650033 on ClinicalTrials.gov

What this trial studies

This is a two‑phase program using daily adaptive radiotherapy (ART) that accounts for day-to-day anatomical changes during pelvic radiation. In phase 1 the study will test the safety and feasibility of a radiation therapist–led ART workflow; if safe, phase 2 will randomize patients to ART with reduced planning margins versus standard image-guided radiotherapy. The interventions use image guidance and on‑table adaptation to update target contours and potentially shrink CTV/PTV margins. The project is being run at Royal North Shore Hospital with prior local RT advanced-practitioner training informing the workflow.

Who should consider this trial

Good fit: Adults (≥18) with pelvic cancers—including prostate requiring nodal treatment or post-prostatectomy, bladder, rectal, anal, adjuvant gynaecological cases, or pelvic nodal disease—who are receiving curative or adjuvant pelvic radiotherapy, have ECOG 0–2, can consent, and meet imaging size limits are ideal candidates.

Not a fit: Patients with hip prostheses, a patient-to-skin separation >24 cm on imaging, those receiving only palliative pelvic radiotherapy, or those unable to tolerate the adaptive workflow are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, this approach could safely reduce radiation-related side effects by allowing smaller treatment margins and improving patients' quality of life.

How similar studies have performed: Prior ART studies have shown promising reductions in acute toxicity, but widespread uptake is limited and RT-led daily adaptive workflows are less well tested, making this approach relatively novel.

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

Where this trial is running

St Leonards, New South Wales

• Northern Sydney Local Health District — St Leonards, New South Wales, Australia (Recruiting)

Study contacts

• Principal investigator: Andrew Kneebone — Northern Sydney Local Health District
• Study coordinator: Nada Cheikh-Ali

Conditions Pelvis Neoplasms