Sim-Free Ethos: Feasibility of Same-Day Phantom-Based Adaptive Palliative Radiotherapy (SPRINT)

November 3, 2026 updated by: University Health Network, Toronto

A Prospective, Phase II, Single-Arm Feasibility Study of Same-Day, Simulation-Free, Phantom-Based Online Adaptive Palliative Radiation

This study evaluates same-day, simulation-free adaptive palliative radiotherapy using an online adaptive radiotherapy platform. The study will assess whether image-guided adaptive radiotherapy can be safely and feasibly delivered within a single day for patients requiring palliative radiation treatment. Participants will receive either a single radiation fraction (8 to 20 Gy) or a hypofractionated regimen (25 to 40 Gy in 3 to 5 fractions), based on clinical requirements. The complete treatment workflow, including consultation, consent, adaptive planning, and treatment delivery, will be completed on the same day. The primary outcome is feasibility, defined as successful generation and delivery of a clinically acceptable adaptive treatment plan on the day of consultation. Secondary outcomes include workflow efficiency, acute toxicity, patient-reported outcomes, patient satisfaction, treatment tolerability, and dosimetric comparison between adaptive plans and standard institutional SBRT benchmarks. Approximately 40 participants will be enrolled and followed for up to 12 months.

The study hypothesizes same-day, simulation-free online adaptive palliative radiotherapy is feasible and safe, allowing timely delivery of clinically acceptable treatment plans without compromising treatment quality or patient experience.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults aged 18 years or older
  • ECOG performance status of 0 to 2 at baseline
  • Patients who are candidates for palliative radiotherapy
  • Patients must have lesions suitable for treatments within the prescribed dose range
  • Patients who are able to provide informed consent
  • Patients who are available for follow-up for at least one month after treatment (interested individuals will be asked in person)

Exclusion Criteria:

  • Prior radiotherapy precluding safe re-irradiation
  • Pregnancy
  • Comorbidities that can increase radiation risk (such as scleroderma or ataxia-telangiectasia)
  • Inability to tolerate supine positioning for approximately thirty minutes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Same-Day Simulation-Free Adaptive Palliative Radiotherapy
Radiation: Simulation-Free Online Adaptive Palliative Radiotherapy

Phantom-Based online adaptive radiotherapy delivered without a conventional simulation appointment. Treatment planning is generated using image-guided adaptive workflows on the day of consultation to enable same-day delivery of palliative radiotherapy. Radiation dose ranges from 8 to 20 Gy in a single fraction or 25 to 40 Gy delivered in 3 to 5 fractions, according to lesion location, target size, and normal tissue constraints.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Same-Day Simulation-Free Adaptive Palliative Radiotherapy
Time Frame: Baseline through 12 months

Defined as the proportion of participants for whom a clinically acceptable adaptive radiotherapy plan meeting predefined clinical goal variations is successfully generated and delivered on the same day as consultation. Feasibility will be expressed as a proportion with an exact 95% confidence interval. A success rate of ≥85% will be considered evidence that same-day adaptive radiotherapy is implementable in clinical practice.
Baseline through 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Workflow Duration
Time Frame: Day of treatment

Time required to complete the simulation-free adaptive radiotherapy workflow, including consultation, consent, treatment planning, and treatment delivery. Workflow interruptions and causes of delays will also be documented.
Day of treatment
Acute Treatment-Related Toxicity
Time Frame: Baseline through 12 months

Incidence and severity of treatment-related adverse events assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 6.0. Toxicities will be summarized by grade, higher grades indicate worse outcomes
Baseline through 12 months
Change in Pain Severity
Time Frame: Baseline through 12 months

Pain will be assessed using the Brief Pain Inventory-Short Form (BPI-SF). Scales ranging from 0 to 10, where 0 indicates no pain/no interference and 10 indicates the worst pain imaginable or complete interference with daily activities. Higher scores indicate worse pain and greater pain-related interference. Changes in pain scores and analgesic use will be evaluated over time.
Baseline through 12 months
Change in Quality of Life
Time Frame: Baseline through 12 months

Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL). For the Global Quality of Life and Functional Scales, higher scores indicate better quality of life or functioning. For the Symptom Scales, higher scores indicate greater symptom burden and worse outcomes.
Baseline through 12 months
Patient Satisfaction With Same-Day Adaptive Radiotherapy
Time Frame: Day of treatment

Patient satisfaction will be assessed using a study-specific questionnaire evaluating treatment tolerability, comfort, communication, and overall experience with the same-day adaptive radiotherapy process.
Day of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

November 3, 2026

First Submitted That Met QC Criteria

November 3, 2026

First Posted (Actual)

November 9, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 25-6037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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