Pelvis Adaptive Radiotherapy (ART)

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Image guided radiotherapy: Standard radiation treatment used in the department of radiation oncology for cancer in pelvic area

Study 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.

Eligibility

Primary outcome measure(s)

• Dose coverage of Clinical Target Volume (CTV) (% of CTV receiving 95% of prescribed dose) will be performed between the two arms (Safety). — 12 months
  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.
• 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). — 12 months
  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.
• The percentage of successfully delivered fractions on the adaptive arm will be measured (feasibility). — 12 months
  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.
• Acute patient reported toxicity — Within 90 days of patients completing treatment
  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.

Trial sites (1)

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