Sim-Free Ethos: Feasibility of Same-Day Phantom-Based Adaptive Palliative Radiotherapy (SPRINT)
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Cancer Center
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Contatto:
- Dana Keilty
- Numero di telefono: 416-946-6513
- Email: dana.keilty@uhn.ca
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Same-Day Simulation-Free Adaptive Palliative Radiotherapy
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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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Feasibility of Same-Day Simulation-Free Adaptive Palliative Radiotherapy
Lasso di tempo: Baseline through 12 months
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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
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Workflow Duration
Lasso di tempo: 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
|
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Acute Treatment-Related Toxicity
Lasso di tempo: Baseline through 12 months
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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
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Change in Pain Severity
Lasso di tempo: 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
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Change in Quality of Life
Lasso di tempo: Baseline through 12 months
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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
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Patient Satisfaction With Same-Day Adaptive Radiotherapy
Lasso di tempo: 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
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 25-6037
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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