A Pilot Study of Focal Ablative STereotactic RAdiosurgery for Cancers of the Kidney or Isolated Adrenal Metastases (FASTRACK)
연구 개요
상세 설명
FASTRACK is a 2 -cohort, non-randomised prospective feasibility study. Anticipated total duration of accrual is approximately 24 months, with all patients expected to complete all protocol treatment and imaging within a further 3 months. The trial will close after the last patient has completed his/her last protocol related follow-up visit (at 12 months post-treatment).
Cohort 1: patients with renal cell carcinoma within the kidney Cohort 2: patients with solitary adrenal metastases from non-small cell lung carcinoma The investigational treatment will be prescribed the covering isodose, ensuring that 99% of the PTV is covered by 100% of the dose (D99=100%). It is anticipated that most treatments should be highly conformal. Treatment must be delivered with at least six (6) non-opposing conformal megavoltage photon beams. It is anticipated that a typical range of beam numbers would be 8 to 12, comprising of at least 6 co-planar beams and 1-2 non-coplanar beams. No cytotoxic chemotherapy is allowed within 3 weeks or concurrently with respect to the investigational treatment. Consultation with the treating radiation oncologist is strongly recommended if chemotherapy is to be considered after the investigational treatment and before documented disease progression, to prevent unforeseen combined toxicities. Targeted agents (such as sunitinib) are exempt from this recommendation.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Victoria
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East Melbourne, Victoria, 호주, 3002
- Peter MacCallum Cancer Centre
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참여기준
자격 기준
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연구 대상 성별
설명
Inclusion Criteria:
- Age > 18 years old
All patients must have radiological diagnosis or biopsy confirmed diagnosis of either:
- Cohort 1: renal cell carcinoma with a single lesion within kidney, or with primary kidney tumour intact and no more than 5 documented metastases, or
- Cohort 2: single adrenal metastases with extra-adrenal disease controlled
- ECOG performance of 0-2 inclusive.
- Either medically inoperable, technically high risk for surgery or decline surgery.
- Informed consent.
Exclusion Criteria:
- 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 upper abdomen
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Radiotherapy
The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size. For lesions <5cm, a single fraction of 26 Gy will be prescribed. For lesions ≥5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size. For lesions <5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The number of patients who complete prescribed treatment.
기간: After 24 months
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This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)
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After 24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Toxicity of SBRT in study patients measured using CTCAE V4.0
기간: Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
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Specific toxicities will include, but are not limited to;
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Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
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Efficacy of stereotactic radiosurgery
기간: 1 year after treatment
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Effective SBRT is defined as a treatment which results in local control at 1 year after treatment.
Local control is defined as lack of progression of the target lesion as measured by RECIST criteria.
RECIST criteria are a CT evaluation of change in tumour size.
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1 year after treatment
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Feasibility of using Diffusion weighted-MRI for response assessment.
기간: At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
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Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.
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At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shankar Siva, Peter MacCallum Cancer Centre, Australia
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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