A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer (SHARP SCLC)
A Randomized Trial of Standard vs. Hypofractionated Accelerated Radiotherapy for Progression in Limited-Stage Small Cell Lung Cancer (SHARP-SCLC)
This study aims to determine whether an abbreviated course of thoracic radiotherapy, delivered in five fractions over one week between chemotherapy cycles, improves progression-free survival compared with standard radiotherapy delivered concurrently with chemotherapy in patients with newly diagnosed limited-stage small cell lung cancer (LS-SCLC).
연구 개요
상태
상세 설명
This is a multicentre, randomized clinical trial comparing two thoracic radiation therapy (RT) approaches for patients with newly diagnosed limited-stage small cell lung cancer (LS-SCLC).
Standard treatment for LS-SCLC involves chemotherapy combined with thoracic radiation therapy. Conventional radiation schedules require daily or twice-daily treatments over several weeks. This study will investigate whether a shorter, accelerated course of radiotherapy can improve progression-free survival while reducing treatment burden.
The primary outcome is progression-free survival, defined as the time from randomization to disease progression or death. Secondary outcomes include overall survival, treatment-related toxicity, patient-reported quality of life, and treatment burden.
The study also includes exploratory translational research involving blood samples and radiation dosimetric analyses to better understand the biological effects of different radiation schedules.
Participants will be followed for up to five years after randomization to assess short- and long-term outcomes.
연구 유형
등록 (추정된)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Melody Qu, MD
- 전화번호: 519-685-8650
- 이메일: Melody.Qu@lhsc.on.ca
연구 장소
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Ontario
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London, Ontario, 캐나다, N6A 5W9
- London Health Sciences Centre, Verspeeten Family Cancer Centre
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연락하다:
- Melody Qu, MD
- 전화번호: 519-685-8650
- 이메일: Melody.Qu@lhsc.on.ca
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수석 연구원:
- Melody Qu, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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New diagnosis of Limited-stage small cell lung cancer (LS-SCLC), eligible for curative intent concurrent chemoradiotherapy
-- Planned for immunotherapy and prophylactic cranial irradiation is allowed and encouraged
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Eastern Cooperative Oncology Group (ECOG) performance status 0-2
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Age 18 years or older
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Life expectancy > 3 months
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Willingness and ability to provide informed consent
Exclusion Criteria:
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Prior thoracic radiation therapy (RT) which, in the opinion of the treating radiation oncologist, precludes the delivery of further thoracic RT
- If there has been prior thoracic RT, a composite of all RT plans must be created, and the dose constraints herein must still be met
- An allowance for 10% repair is permitted if at least 12 months have passed between the prior RT and the trial protocol specified RT
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Serious medical comorbidities which, in the opinion of the treating radiation oncologist, preclude the delivery of RT
-- This includes interstitial lung disease
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Patients who have started systemic treatment for LS-SCLC but are unable to start radiation with cycle 3 or earlier (delaying scheduled chemotherapy without clinical indication) is not permitted
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Pregnant or lactating women
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Inability to attend the full course of RT or planed follow-up visits
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Standard Thoracic Radiotherapy
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Standard RT using VMAT or IMRT. Accepted standard-of-care fractionation schedules include:
4-6 cycles of intravenous (IV) cisplatin (75 mg/m2) or carboplatin (area under the curve of 5-6 mg/mL × min) given on day 1 or day 1-3 and etoposide (100 mg/m2) on days 1 to 3 every 3 weeks. Oral etoposide (200 mg/m²) is permitted in urgent situations and/or when IV etoposide is not feasible, at the treating clinician's discretion. |
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실험적: Hypofractionated Accelerated Thoracic Radiotherapy
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4-6 cycles of intravenous (IV) cisplatin (75 mg/m2) or carboplatin (area under the curve of 5-6 mg/mL × min) given on day 1 or day 1-3 and etoposide (100 mg/m2) on days 1 to 3 every 3 weeks. Oral etoposide (200 mg/m²) is permitted in urgent situations and/or when IV etoposide is not feasible, at the treating clinician's discretion. Hypofractionated radiotherapy using VMAT or IMRT, prescribed to a total dose of 35 Gy in 5 fractions, with a SIB to 40 Gy for GTV where feasible. Radiotherapy will begin as early as feasible, preferably during chemotherapy cycle 1 or 2, and no later than cycle 3. Radiation will be delivered between chemotherapy cycles, ideally on days 15-20 of the respective cycle to avoid the anticipated chemotherapy nadir, and will not be administered on chemotherapy treatment days. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Progression-free survival
기간: From randomization to disease progression or death, assessed for up to 60 months.
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Progression-free survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first. Disease progression will be assessed using RECIST version 1.1 criteria. Participants without documented progression or death will be censored at the date of their last adequate disease assessment. |
From randomization to disease progression or death, assessed for up to 60 months.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Quality of Life Measured by the Functional Assessment of Cancer Therapy: Lung (FACT-L), and EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaires
기간: From randomization to 60 months post-randomization
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Changes in quality of life as reported by the participant on the Functional Assessment of Cancer Therapy: Lung (FACT-L) and EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaires |
From randomization to 60 months post-randomization
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Acute and Chronic Physician-Reported Toxicity Using Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
기간: From randomization to 60 months post-randomization
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Severity and grade of side effects of treatment as reported by the physician as grade 2 or greater, using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
From randomization to 60 months post-randomization
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Overall Survival
기간: From randomization to 60 months post-randomization
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Overall survival defined as time from randomization to death from any cause, or last follow-up, whichever occurs first |
From randomization to 60 months post-randomization
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Freedom From Intrathoracic Progression
기간: From randomization to 60 months post-enrollment
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Freedom From Intrathoracic Progression defined as time from randomization to disease progression with the thorax, or last follow-up, whichever occurs first. |
From randomization to 60 months post-enrollment
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Freedom From Intracranial Progression
기간: From randomization to 60 months post-randomization
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Freedom From Intracranial Progression defined as time from randomization to disease progression intracranially, or last follow-up, whichever occurs first. |
From randomization to 60 months post-randomization
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Cost-Effectiveness Analysis
기간: From randomization to 60 months post-randomization
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Patient-level data on survival, disease progression, treatment-related toxicity, healthcare utilization, and health-related quality of life (EQ-5D-5L) will inform a cost-effectiveness analysis, based on modelled costs and quality-adjusted life years. |
From randomization to 60 months post-randomization
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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