ClinicalTrials.gg
Not yet recruitingNCT07925385SPRINTUpdated Nov 9, 2026

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

An interventional study of Simulation-Free Online Adaptive Palliative Radiotherapy in Palliative Radiotherapy, sponsored by University Health Network, Toronto. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Supportive care

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Palliative Radiotherapy
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18 years or older
  • 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
  • Patients who are available for follow-up for at least one month after treatment (interested individuals will be asked in person)

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Same-Day Simulation-Free Adaptive Palliative Radiotherapy

    Radiation: Simulation-Free Online Adaptive Palliative Radiotherapy

Interventions

  • RadiationSimulation-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.

06

What researchers measure

Primary outcomes

  1. Feasibility of Same-Day Simulation-Free Adaptive Palliative Radiotherapy

    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.

    Time frame: Baseline through 12 months

Secondary outcomes

  1. Workflow Duration

    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.

    Time frame: Day of treatment

  2. Acute Treatment-Related Toxicity

    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

    Time frame: Baseline through 12 months

  3. Change in Pain Severity

    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.

    Time frame: Baseline through 12 months

  4. Change in Quality of Life

    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.

    Time frame: Baseline through 12 months

  5. Patient Satisfaction With Same-Day Adaptive Radiotherapy

    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.

    Time frame: Day of treatment

07

Study locations

1 site
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07925385
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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