이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

올리고전이/진행의 포괄적인 치료를 위한 정위 절제 방사선 요법의 단일 대 다중 분할 시험

2026년 9월 22일 업데이트: Robert Olson

올리고 전이/진행의 종합 치료를 위한 정위 절제 방사선 요법의 단일 대 다중 분할 비열등성 시험: SIMPLIFY-SABR-COMET

Stereotactic Ablative Radiotherapy (SABR) is a modern RT technique that delivers high doses of radiation to small tumor targets using highly conformal techniques, while trying to avoid healthy tissues and organs. However, SABR treatment requires increased planning, treatment time, cost and potential for higher toxicity due to the higher dose. The purpose of this study is to compare single fraction (SF) SABR vs. multiple fraction (MF) SABR in regards to toxicities, progression-free survival, quality of life (QoL), and cost-effectiveness. In a subset of patients, we will also compare patient QoL, hospitalization rates, and cost-effectiveness between patients who complete QoL questionnaires, record symptoms and receive healthcare provider-guided intervention vs. patients who complete QoL questionnaires only.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

Radiation can be delivered in multiple fractions, or doses, and can take up to several weeks or months of treatment depending on the type of cancer. Radiation can also be offered in a single fraction. Both techniques have evidence for use in clinical care. Multiple fraction is offered to reduce the amount of radiation given at a single time that could reduce late toxicities. However, single fraction radiotherapy is more cost-effective and saves patient time. With this trial, we will compare single fraction vs. multiple fraction in regards to their impact on toxicity, progression-free survival: time from randomization to disease progression at any site or death, lesional control rate: lesion size post-SABR, quality of life and cost-effectiveness.

In a subset of sites, we will also investigate the impact of healthcare-provider guided intervention on quality of life. Questionnaires capture various symptoms such as pain, fatigue and information relating to physical, social, and mental wellbeing. This information can help shed light on patient experience and provide a better understanding of the effects of radiation therapy. In this trial, we will compare quality of life questionnaire completion, symptom reporting and healthcare-provider guided intervention vs. quality of life questionnaire completion alone, in regards to patient quality of life. Hospitalization rates and frequency of emergency department visits will also be investigated.

Sample size: The total sample size of 598 for this trial was calculated based on the primary endpoint of toxicity for the single vs. multiple fraction SABR randomization. Calculations were performed based on the results of the SABR-5 trial and our clinical judgement.

Quality Assurance: Radiation treatments are based on the current phase III SABR-COMET-3 trial and as per recent clinical evidence. All treatments will be planned as per protocol including computed tomography (CT) simulation, organs at risk contouring and undergo a quality assurance process.

For the subset of sites involved in the second randomization, training will be provided to patients on the use of Noona, a patient-reported outcome platform.

연구 유형

중재적

등록 (추정된)

598

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

    • Connacht
      • Galway, Connacht, 아일랜드, H91 YR71
        • 모병
        • University Hospital Galway
        • 연락하다:
        • 수석 연구원:
          • Ronan McDermott
    • Dublin
      • Dublin, Dublin, 아일랜드, D06 E1C9
        • 모병
        • St. Luke's Radiation Oncology Network
        • 연락하다:
        • 수석 연구원:
          • Lorna Keenan
    • Leinster
      • Dublin, Leinster, 아일랜드, D18 AK68
      • Dublin, Leinster, 아일랜드, D07 WKW8
        • 모병
        • Mater Private Hospital
        • 연락하다:
        • 수석 연구원:
          • Daniel Cagney
    • Munster
      • Cork, Munster, 아일랜드, T12 DV56
        • 모병
        • Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre
        • 수석 연구원:
          • Paul Kelly
        • 연락하다:
      • Cork, Munster, 아일랜드, T12 DC4A
        • 모병
        • Cork University Hospital
        • 연락하다:
        • 수석 연구원:
          • Aisling Barry
      • Waterford, Munster, 아일랜드, X91 DH9W
        • 모병
        • UPMC Whitfield Hospital - Waterford
        • 연락하다:
        • 수석 연구원:
          • Ciara Lyons
    • British Columbia
      • Kelowna, British Columbia, 캐나다
      • Prince George, British Columbia, 캐나다, V2M 7E9
      • Surrey, British Columbia, 캐나다
      • Vancouver, British Columbia, 캐나다
        • 모병
        • BC Cancer
        • 연락하다:
      • Victoria, British Columbia, 캐나다
        • 아직 모집하지 않음
        • BC Cancer - Victoria
        • 연락하다:
    • Ontario
      • Greater Sudbury, Ontario, 캐나다, P3E 5J1
        • 모병
        • Health Sciences North Research Institute
        • 수석 연구원:
          • Andrew Pearce
        • 연락하다:
      • Toronto, Ontario, 캐나다, M5G 1X6
        • 모병
        • Princess Margaret Cancer Centre | University Health Network
        • 수석 연구원:
          • Chiaojung Jillian Tsai
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 1-5 current oligometastatic or oligo-progressive lesions

  • Age 18 years or older

  • Able to provide informed consent

  • Able to complete electronic entry of patient reported outcomes and questionnaires independently or with assistance from a caregiver/family/friend/research staff using electronic methods after providing consent to email use.

  • Life expectancy > 6 months

  • Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • Controlled primary tumor: defined as at least 3 months since original tumor treated radically, with no progression at primary site (can be considered controlled if no evidence of the primary tumour on imaging [e.g. primary unknown])

  • A history including ECOG performance status, performed within 6 weeks prior to enrollment

  • Patient has had a CT chest, abdomen and pelvis or PET-CT within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • Patient has had a nuclear bone scan (if no positron emission tomography-computed tomography [PET-CT]) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • Patient has had CT or MRI brain imaging if primary has a propensity for central nervous system metastases (if deemed appropriate by the treating investigator) within 10 weeks prior to enrollment, and within 13 weeks prior to treatment.

  • For patients with known spine metastases, patient has had MRI spine imaging within 10 weeks prior to enrollment, and with 13 weeks prior to treatment.

  • If solitary lung nodule for which biopsy is unsuccessful or not possible, patient has had an FDG (fluorodeoxyglucose) PET scan or CT (chest, abdomen, pelvis) and bone scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • If colorectal primary with rising Carcinoembryonic antigen (CEA), but equivocal imaging, patient has had an FDG PET scan within 10 weeks prior to enrollment, and within 13 weeks prior to treatment

  • Patient is judged able to:

    • Maintain a stable position during therapy
    • Tolerate immobilization device(s) that may be required to deliver SABR safely
  • Negative pregnancy test for People of Child-Bearing Potential (POCBP) within 4 weeks of RT start date

Exclusion Criteria:

  • Uncontrolled concurrent malignant cancer

  • Lesion in femoral bone requiring surgical fixation

  • No chemotherapy agents (cytotoxic, or molecularly targeted agents) will be used within the period of time commencing 1 week prior to radiation, lasting until 1 week after the last fraction. See section 5.3.3 regarding this criterion.

  • Serious medical comorbidities precluding radiotherapy. These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the gastrointestinal (GI) tract will receive radiotherapy, and connective tissue disorders such as lupus or scleroderma.

  • Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated with radiation previously, similar biological effective dose calculations should be used to equate previous doses to the tolerance doses listed below. All such cases should be discussed with the local and study principal investigators (PIs).

  • Current malignant pleural effusion

  • Liver metastases located in the "Biliary no fly zone" defined for this trial as common biliary track, cystic duct and distal branches (1 cm) + 5 mm.

  • Inability to treat all sites of oligometastatic or oligoprogressive disease (all lesions must be suitable for both single- and multi-fraction SABR)

  • Presence of brain metastases as the sole site of disease

  • Maximum size of 5 cm for lesions outside the brain, except:

    • Bone metastases over 5 cm may be included, if in the opinion of the local PI it can be treated safely (e.g. rib, scapula, pelvis)
  • Any brain metastasis > 3.5 cm in size or a total volume of brain metastases greater than 30 cc is excluded

  • Clinical or radiologic evidence of spinal cord compression. Patients can be eligible if surgical resection has been performed

  • Patients with spine instability as judged by a Spinal Instability Neoplastic Score (SINS) of >12

  • Dominant brain metastasis requiring surgical decompression

  • Surgical resection of all metastases (i.e. no lesion available to be treated with SABR)

  • Complete response to systemic therapy, defined as the absence of visible disease on imaging

  • Pregnant or breast feeding

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 요인 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Multiple fraction SABR (Arm 1)

Participants randomized to this arm will receive multiple fraction SABR

Participants randomized to this arm will receive MF SABR:

Dose/Fractionation are as follows:

Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory organ-at-risk (OAR) constraints are met: 48 Gy in 4 fractions (12 Gy/#), 54 Gy in 3 fractions (18 Gy/#), daily or every second day

Lung: Within 2 cm of mediastinum or brachial plexus 60 Gy in 8 fractions (7.5 Gy/#), 50 Gy in 5 fractions (10 Gy/#), daily

Bone: Any bone except spine: 35 Gy in 5 fractions (7 Gy/#), daily

Liver: 54 Gy in 3 fractions (18 Gy/#) or 5 fractions (10.8 Gy/#), daily or every second day

Spine: 24 Gy in 2 fractions (12 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Adrenal: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Lymph node/soft tissue: 40 Gy in 5 fractions (8 Gy/#) or 35 Gy in 5 fractions (7 Gy/#), daily

Brain - dose per institutional policy for stereotactic lesions (no whole brain RT).

실험적: Single fraction SABR (Arm 2)

Participants randomized to this arm will receive single fraction SABR

Participants randomized to this arm will receive SF SABR

Treatment recommendations are as follows:

Lung: Greater than 2 cm from mediastinum or brachial plexus or if mandatory OAR constraints are met: 30 Gy in 1 fraction

Lung: Within 2 cm of mediastinum or brachial plexus 20 Gy in 1 fraction

Bone, Spine, Adrenal, lymph node/soft tissue: 20 Gy in 1 fraction

Liver: 30 Gy in 1 fraction

Brain: dose as per institutional policy

활성 비교기: Patient-reported outcome (PRO) collection : QoL reporting alone (Arm A)

Participants will complete the EuroQoL-5Dimensions-5levels (EQ-5D-5L) and Functional Assessment of Cancer Therapy-General (FACT-G) prior to each scheduled follow-up (FU).

Participants randomized to this arm will complete the EQ-5D-5L and FACT-G at baseline and each follow-up visit

실험적: QoL reporting and healthcare provider (HCP) intervention guided by symptom screen (Arm B)
  • Patients complete EQ-5D-5L and FACT-G prior to each scheduled FU
  • Patient complete online adaptive symptom screen with HCP intervention, prior to each scheduled appointment

Participants randomized to this arm will complete the FACT,G, EQ-5D-5L, radiation-symptom screen and receive healthcare provider-guided intervention based on their symptom reports.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Adverse events
기간: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Occurrences and changes in grade 3 or higher adverse events related to treatment, according to CTCAE v5.0

At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Change in patient-reported quality of life
기간: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

As measured by the EQ-5D-5L. This questionnaire provides measures for mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. It also includes a numbered scale from 0 to 100 where 100 means the best health one can imagine, and 0 means the worst health one can imagine.

At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

2차 결과 측정

결과 측정
측정값 설명
기간
Lesional control rate
기간: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Rate is determined based on lesion size post-SABR using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Progression-free survival
기간: At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Time from randomization to disease progression at any site or death

At 6 weeks, 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months
Overall survival
기간: Approximately at the end of year 5 of follow-up, at study completion

Time from randomization to death from any cause (exploratory)

Approximately at the end of year 5 of follow-up, at study completion
Resource utilization
기간: At 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

Assessed via patient- and provider-reported hospitalization rates, frequency of emergency department visits, number of patients with systemic or radiation therapy post SABR treatment on trial

At 3 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, 60 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

  • 수석 연구원: Robert Olson, MD, MSc, FRCPC, BC Cancer - Prince George

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2025년 4월 16일

기본 완료 (추정된)

2035년 4월 30일

연구 완료 (추정된)

2035년 5월 30일

연구 등록 날짜

최초 제출

2023년 2월 28일

QC 기준을 충족하는 최초 제출

2023년 3월 23일

처음 게시됨 (실제)

2023년 3월 24일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 24일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 22일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

기타 연구 ID 번호

  • SIMPLIFY-SABR-COMET

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .