DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy

Study Overview
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Brief Summary
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The objective of this trial is to assess the efficacy, acceptability, and scalability of diagnostic-CT-enabled planning, compared to conventional CT simulation planning.

Official Title
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DART: Diagnostic-CT-Enabled Planning: A Randomized Trial in Palliative Radiation Therapy

Conditions
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Advanced Cancer Requiring Palliative Radiation

Intervention / Treatment
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* Diagnostic Test: Diagnostic-CT-enabled Planning
* Diagnostic Test: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years or older Able to provide informed consent Patient has consented to PRT to bone/soft tissue metastases or primary targets in the thorax, abdomen, or pelvis and RO will use simple planning techniques (i.e. parallel-opposed pair or direct field beam arrangement) Patient will be scheduled for same-day simulation and treatment (if randomized to Arm 1) Patient has a pre-existing and recent (i.e. within 4 weeks of time of enrollment) diagnostic CT or CT-fused scan with full visualization of the region-of-interest which has been acquired from an approved diagnostic scanner Patient positioning scan is deemed acceptable and reproducible (e.g., patient is lying supine and relatively flat, there is no/minimal motion blur, ect.) Intravenous (IV)/oral contrast in the region-of-interest is permitted as long as it does not create artifact which obscured the target volume (density override calculations may be required) Exclusion Criteria: Any contraindication to receiving radiation Oncologic emergencies and/or on-call cases Pregnant or lactating women Cases requiring composite dosimetric planning to account for previous radiotherapy or extended distance set-up

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br>Patients will be booked for CT simulation and treatment as per the local institution's standard practice. | Diagnostic Test: Standard of Care<br>* Patients will be booked for CT simulation and treatment as per the local institution's standard practice<br>|
| Experimental: Experimental Treatment Workflow<br>Patients do not require a CT simulation appointment. A radiation treatment appointment will be scheduled on an optical surface guidance-equipped treatment unit as soon as available, but a minimum of 24 hours is required between EBAF processing and fraction 1. | Diagnostic Test: Diagnostic-CT-enabled Planning<br>* Diagnostic-CT-enabled planning for patient receiving palliative radiation treatment to bone, soft tissue and lung disease<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in Centre (TIC) on Treatment Day | This is defined as the total time in hours spent at the cancer centre from the scheduled CT simulation (Arrm 1) or treatment delivery (Arm 2) appointment until beam delivery completion. | 1 Treatment Day |