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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Ontario
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Toronto, Ontario, 캐나다, M5G 2M9
- Princess Margaret Cancer Center
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연락하다:
- Dana Keilty
- 전화번호: 416-946-6513
- 이메일: dana.keilty@uhn.ca
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
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실험적: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Feasibility of Same-Day Simulation-Free Adaptive Palliative Radiotherapy
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Workflow Duration
기간: Day of treatment
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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
기간: 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
기간: Baseline through 12 months
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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
기간: 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
기간: Day of treatment
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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
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 25-6037
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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