신장암에 대한 국소 절제 정위 방사선 수술 (FASTRACK II)
신장암에 대한 국소 절제 정위 방사선 수술, 2상 임상 시험(FASTRACK II)
This study is evaluating the activity and efficacy of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of kidney cancers.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Who is it for?
- Age > 18 years old
- All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
- ECOGperformance of 0-2 inclusive.
- Life expectancy > 9 months
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Multidisciplinary decision for active treatment
Study Details:
Definitive external beam radiotherapy (EBRT) is often used to treat medically inoperable patients with cancers in many different organs, including the kidneys. However, renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated EBRT in the form of stereotactic radiotherapy has renewed interest in the management of renal cell carcinoma with radiotherapy. This study will be evaluating the safety and effectiveness of Stereotactic Ablative Body Radiotherapy (SABR) for the treatment of cancers of the kidney.
Participants in this study will be allocated to receive either multi-fraction SABR (3 fractions over 2 weeks) or single fraction SABR (1 fraction only).
All participants will be assessed at regular intervals post treatment in order to estimate the activity and efficacy of the technique, evaluate tolerability, estimate survival, estimate distant failure rate, and renal function change after SABR.
The follow-up visits occur at 4 weeks and every 3 months in the 1st year post treatment, then every 6 months in the second year and then yearly until study closure (2 years after the last participant finishes study treatment).
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 장소
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Victoria
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East Melbourne, Victoria, 호주, 3000
- Peter MacCallum Cancer Centre
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age > 18 years old
- All patients must have a biopsy confirmed diagnosis of renal cell carcinoma with a single lesion within a kidney
- Eastern Cooperative Oncology Group (ECOG) performance of 0-2 inclusive.
- Life expectancy > 9 months
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Multidisciplinary decision for active treatment
Exclusion Criteria:
- Pre-treatment estimated glomerular filtration rate < 30 mls/min
- Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Delivery of targeted agents (such as sunitinib) are allowable only when at least 7 days separate the delivery of the proposed agent and the delivery of the stereotactic radiotherapy.
- Previous high-dose radiotherapy to an overlapping region
- Tumours of larger than 8cm is size
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 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: Stereotactic Ablative Body Radiotherapy
Stereotactic Ablative Body Radiotherapy (SABR) Treatment schedule 1: 26 Gray (Gy) in 1 fraction, for tumours of less than or equal to 4cm in size. Treatment schedule 2: 42 Gray (Gy) in 3 fractions, for tumours of greater than 4cm in size |
Renal cell carcinoma (RCC) is conventionally considered "radioresistant" to fully fractionated EBRT. In an effort to overcome the perceived "radioresistance" of RCC, severely hypofractionated External beam radiation therapy (EBRT) in the form of stereotactic radiotherapy will be used in the management of renal cell carcinoma with radiotherapy.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Activity and efficacy of SABR measured by Freedom from local progression assessed by RECIST Criteria
기간: 12mths post treatment
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Responsive Evaluation Criteria in Solid Tumors (RECIST) |
12mths post treatment
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CT 스캔 및 임상 평가에 의해 평가된 SABR 후 예상 원거리 실패율
기간: 무작위 배정 날짜부터 치료 후 6개월, 9개월, 12개월, 18개월, 33개월, 42개월, 51개월, 60개월에 평가한 첫 번째 문서 진행 날짜 또는 모든 원인으로 인한 사망 날짜 중 먼저 도래하는 날짜까지
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무작위 배정 날짜부터 치료 후 6개월, 9개월, 12개월, 18개월, 33개월, 42개월, 51개월, 60개월에 평가한 첫 번째 문서 진행 날짜 또는 모든 원인으로 인한 사망 날짜 중 먼저 도래하는 날짜까지
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Tolerability of SABR Assessed as cummulative incedents of severe toxicity by CTCAE v4
기간: From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment
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Common Terminology Criteria for Adverse Events (CTCAE) |
From date of treatment commencement until first documented progression or date of death from any cause, whichever came first, assessed from 4wks, 3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mth post treatment
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Estimated Survival after SABR assessed by clinincal assessment
기간: assessed up to 60 months
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Stereotactic Ablative Radiotherapy (SABR) |
assessed up to 60 months
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Renal Function Change after SABR assessed by split renal function and GFR
기간: Baseline, 12mths post treatment, and 24 mths post treatment
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Calculated Glomular Filtration Rate (GFR) |
Baseline, 12mths post treatment, and 24 mths post treatment
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Renal Function Change after SABR assessed by using eGFR
기간: Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths
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Estimated Glomular Filtration Rate (eGFR) |
Baseline,3 mths, 6 mths, 9mths, 12 mths, 18 mths, 24 mths, 33 mths, 42 mths, 51 mths, and 60 mths
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Shankar Siva, A/Prof, Peter MacCallum Cancer Centre, Australia
간행물 및 유용한 링크
일반 간행물
- Siva S, Chesson B, Bressel M, Pryor D, Higgs B, Reynolds HM, Hardcastle N, Montgomery R, Vanneste B, Khoo V, Ruben J, Lau E, Hofman MS, De Abreu Lourenco R, Sridharan S, Brook NR, Martin J, Lawrentschuk N, Kron T, Foroudi F. TROG 15.03 phase II clinical trial of Focal Ablative STereotactic Radiosurgery for Cancers of the Kidney - FASTRACK II. BMC Cancer. 2018 Oct 23;18(1):1030. doi: 10.1186/s12885-018-4916-2.
- Siva S, Ali M, Hardcastle N, Kron T, Higgs B, Foroudi F, Ruben J, Appu S, Martin J, Sridharan S, Montgomery R, Davey R, Lin C, Shaw M, Chander S, Sidhom M, Vanneste BGL, Murphy DG, Lawrentschuk N, Pryor D, Wood S, Moon D, Bressel M. Ultra-hypofractionated stereotactic ablative body radiotherapy for primary renal cell carcinoma: 5-year outcomes from a pooled analysis of the FASTRACK trials. Lancet Oncol. 2026 Jun;27(6):721-728. doi: 10.1016/S1470-2045(26)00170-1. Epub 2026 May 17.
- Siva S, Pryor D, Martin J, Hardcastle N, Moon D, Kron T, Higgs B, Foroudi F, Ruben J, Sridharan S, Montgomery R, Davey R, Lin C, Shaw M, Lawrentschuk N, Appu S, Vanneste BGL, Hofman MS, Murphy DG, De Abreu Lourenco R, Mancuso P, Brook NR, Raman A, Wong LM, Sidhom M, Wood S, Ali M, Bressel M. Long-term outcomes of stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a multicentre, non-randomised, phase 2 study. Lancet Oncol. 2026 Jun;27(6):711-720. doi: 10.1016/S1470-2045(26)00091-4. Epub 2026 May 17.
- Siva S, Bressel M, Sidhom M, Sridharan S, Vanneste BGL, Davey R, Montgomery R, Ruben J, Foroudi F, Higgs B, Lin C, Raman A, Hardcastle N, Hofman MS, De Abreu Lourenco R, Shaw M, Mancuso P, Moon D, Wong LM, Lawrentschuk N, Wood S, Brook NR, Kron T, Martin J, Pryor D; FASTRACK II Investigator Group. Stereotactic ablative body radiotherapy for primary kidney cancer (TROG 15.03 FASTRACK II): a non-randomised phase 2 trial. Lancet Oncol. 2024 Mar;25(3):308-316. doi: 10.1016/S1470-2045(24)00020-2.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정된)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- TROG 15.03
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