올리고전이/진행의 포괄적인 치료를 위한 정위 절제 방사선 요법의 단일 대 다중 분할 시험
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
상태
정황
정황
개입 / 치료
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
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Robert Olson, MD, MSC, FRCPC
- 전화번호: 250-645-7300
- 이메일: rolson2@bccancer.bc.ca
연구 연락처 백업
- 이름: Hadassah Abraham, MSc
- 전화번호: 250-645-7300
- 이메일: hadassah.abraham@bccancer.bc.ca
연구 장소
-
-
Connacht
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Galway, Connacht, 아일랜드, H91 YR71
- 모병
- University Hospital Galway
-
연락하다:
- Helen McLoughlin
- 전화번호: 091 542600
- 이메일: Helen.McLoughlin6@hse.ie
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수석 연구원:
- Ronan McDermott
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Dublin
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Dublin, Dublin, 아일랜드, D06 E1C9
- 모병
- St. Luke's Radiation Oncology Network
-
연락하다:
- Roisin O'Maolalai
- 전화번호: 0035314065458
- 이메일: roisin.omaolalai@slh.ie
-
수석 연구원:
- Lorna Keenan
-
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Leinster
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Dublin, Leinster, 아일랜드, D18 AK68
- 모병
- Beacon Hospital
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연락하다:
- Roisin Conaty
- 전화번호: 353 1 293 6600
- 이메일: roisin.conaty@beaconhospital.ie
-
수석 연구원:
- Alina Mihai
-
Dublin, Leinster, 아일랜드, D07 WKW8
- 모병
- Mater Private Hospital
-
연락하다:
- Lisa Scahill
- 전화번호: +353 (1) 8034831
- 이메일: lscahill@mater.ie
-
수석 연구원:
- Daniel Cagney
-
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Munster
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Cork, Munster, 아일랜드, T12 DV56
- 모병
- Bon Secours Radiotherapy Cork in Partnership with UPMC Hillman Cancer Centre
-
수석 연구원:
- Paul Kelly
-
연락하다:
- Erica Bennett
- 전화번호: +353 21-486-11
- 이메일: bennette10@upmc.ie
-
Cork, Munster, 아일랜드, T12 DC4A
- 모병
- Cork University Hospital
-
연락하다:
- Murtaza Gangardiwala
- 전화번호: 021 4234807
- 이메일: murtaza.gangardiwala@hse.ie
-
수석 연구원:
- Aisling Barry
-
Waterford, Munster, 아일랜드, X91 DH9W
- 모병
- UPMC Whitfield Hospital - Waterford
-
연락하다:
- Erica Bennett
- 이메일: bennette10@upmc.ie
-
수석 연구원:
- Ciara Lyons
-
-
-
-
British Columbia
-
Kelowna, British Columbia, 캐나다
- 모병
- BC Cancer
-
연락하다:
- Benjamin Mou, MD
- 전화번호: 250-712-3900
- 이메일: benjamin.mou@bccancer.bc.ca
-
Prince George, British Columbia, 캐나다, V2M 7E9
- 모병
- BC Cancer
-
연락하다:
- Robert A Olson, MD
- 전화번호: 2506457300
- 이메일: rolson2@bccancer.bc.ca
-
연락하다:
- Hadassah Abraham
- 전화번호: 2506457300
- 이메일: hadassah.abraham@bccancer.bc.ca
-
수석 연구원:
- Robert A Olson
-
Surrey, British Columbia, 캐나다
- 모병
- BC Cancer
-
연락하다:
- Devin Schellenberg, MD
- 전화번호: 604-930-2098
- 이메일: dschellenberg@bccancer.bc.ca
-
Vancouver, British Columbia, 캐나다
- 모병
- BC Cancer
-
연락하다:
- Mitchell Liu, MD
- 전화번호: 6048776000
- 이메일: mliu@bccancer.bc.ca
-
Victoria, British Columbia, 캐나다
- 아직 모집하지 않음
- BC Cancer - Victoria
-
연락하다:
- Boris Valev, MD
- 전화번호: 250-519-5500
- 이메일: boris.valev@bccancer.bc.ca
-
-
Ontario
-
Greater Sudbury, Ontario, 캐나다, P3E 5J1
- 모병
- Health Sciences North Research Institute
-
수석 연구원:
- Andrew Pearce
-
연락하다:
- Jessica Richer
- 전화번호: 1922 705.522.6237
- 이메일: jricher@hsnri.ca
-
Toronto, Ontario, 캐나다, M5G 1X6
- 모병
- Princess Margaret Cancer Centre | University Health Network
-
수석 연구원:
- Chiaojung Jillian Tsai
-
연락하다:
- Yoona Shin
- 전화번호: 416-946-4558
- 이메일: yoona.shin@uhn.ca
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
1-5 current oligometastatic or oligo-progressive lesions
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Age 18 years or older
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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
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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])
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A history including ECOG performance status, performed within 6 weeks prior to enrollment
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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
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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
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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.
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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
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 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)
|
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
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
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
수사관
수사관
- 수석 연구원: Robert Olson, MD, MSc, FRCPC, BC Cancer - Prince George
간행물 및 유용한 링크
일반 간행물
- Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, Bonsel G, Badia X. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011 Dec;20(10):1727-36. doi: 10.1007/s11136-011-9903-x. Epub 2011 Apr 9.
- Hellman S, Weichselbaum RR. Oligometastases. J Clin Oncol. 1995 Jan;13(1):8-10. doi: 10.1200/JCO.1995.13.1.8. No abstract available.
- Cella DF, Tulsky DS, Gray G, Sarafian B, Linn E, Bonomi A, Silberman M, Yellen SB, Winicour P, Brannon J, et al. The Functional Assessment of Cancer Therapy scale: development and validation of the general measure. J Clin Oncol. 1993 Mar;11(3):570-9. doi: 10.1200/JCO.1993.11.3.570.
- Cox BW, Spratt DE, Lovelock M, Bilsky MH, Lis E, Ryu S, Sheehan J, Gerszten PC, Chang E, Gibbs I, Soltys S, Sahgal A, Deasy J, Flickinger J, Quader M, Mindea S, Yamada Y. International Spine Radiosurgery Consortium consensus guidelines for target volume definition in spinal stereotactic radiosurgery. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e597-605. doi: 10.1016/j.ijrobp.2012.03.009. Epub 2012 May 19.
- Olson R, Mathews L, Liu M, Schellenberg D, Mou B, Berrang T, Harrow S, Correa RJM, Bhat V, Pai H, Mohamed I, Miller S, Schneiders F, Laba J, Wilke D, Senthi S, Louie AV, Swaminath A, Chalmers A, Gaede S, Warner A, de Gruijl TD, Allan A, Palma DA. Stereotactic ablative radiotherapy for the comprehensive treatment of 1-3 Oligometastatic tumors (SABR-COMET-3): study protocol for a randomized phase III trial. BMC Cancer. 2020 May 5;20(1):380. doi: 10.1186/s12885-020-06876-4.
- Patel PH, Palma D, McDonald F, Tree AC. The Dandelion Dilemma Revisited for Oligoprogression: Treat the Whole Lawn or Weed Selectively? Clin Oncol (R Coll Radiol). 2019 Dec;31(12):824-833. doi: 10.1016/j.clon.2019.05.015. Epub 2019 Jun 8.
- Nguyen TK, Chin L, Sahgal A, Dagan R, Eppinga W, Guckenberger M, Kim JH, Lo SS, Redmond KJ, Siva S, Stish BJ, Chan R, Lawrence L, Lau A, Tseng CL. International Multi-institutional Patterns of Contouring Practice and Clinical Target Volume Recommendations for Stereotactic Body Radiation Therapy for Non-Spine Bone Metastases. Int J Radiat Oncol Biol Phys. 2022 Feb 1;112(2):351-360. doi: 10.1016/j.ijrobp.2021.09.004. Epub 2021 Sep 9.
- Redmond KJ, Robertson S, Lo SS, Soltys SG, Ryu S, McNutt T, Chao ST, Yamada Y, Ghia A, Chang EL, Sheehan J, Sahgal A. Consensus Contouring Guidelines for Postoperative Stereotactic Body Radiation Therapy for Metastatic Solid Tumor Malignancies to the Spine. Int J Radiat Oncol Biol Phys. 2017 Jan 1;97(1):64-74. doi: 10.1016/j.ijrobp.2016.09.014. Epub 2016 Sep 17.
- Dunne EM, Sahgal A, Lo SS, Bergman A, Kosztyla R, Dea N, Chang EL, Chang UK, Chao ST, Faruqi S, Ghia AJ, Redmond KJ, Soltys SG, Liu MC. International consensus recommendations for target volume delineation specific to sacral metastases and spinal stereotactic body radiation therapy (SBRT). Radiother Oncol. 2020 Apr;145:21-29. doi: 10.1016/j.radonc.2019.11.026. Epub 2019 Dec 23.
- Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, Mendoza TR, Hay J, Atkinson TM, Abernethy AP, Bruner DW, Cleeland CS, Sloan JA, Chilukuri R, Baumgartner P, Denicoff A, St Germain D, O'Mara AM, Chen A, Kelaghan J, Bennett AV, Sit L, Rogak L, Barz A, Paul DB, Schrag D. Development of the National Cancer Institute's patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014 Sep 29;106(9):dju244. doi: 10.1093/jnci/dju244. Print 2014 Sep.
- Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
- Common Terminology Criteria for Adverse Events (CTCAE) Common Terminology Criteria for Adverse Events (CTCAE) v5.0. 2017
- Olson R, Abraham H, Leclerc C, Benny A, Baker S, Matthews Q, Chng N, Bergman A, Mou B, Dunne EM, Schellenberg D, Jiang W, Chan E, Atrchian S, Lefresne S, Carolan H, Valev B, Tyldesley S, Bang A, Berrang T, Clark H, Hsu F, Louie AV, Warner A, Palma DA, Howell D, Barry A, Dawson L, Grendarova P, Walker D, Sinha R, Tsai J, Bahig H, Thibault I, Koul R, Senthi S, Phillips I, Grose D, Kelly P, Armstrong J, McDermott R, Johnstone C, Vasan S, Aherne N, Harrow S, Liu M. Single vs. multiple fraction non-inferiority trial of stereotactic ablative radiotherapy for the comprehensive treatment of oligo-metastases/progression: SIMPLIFY-SABR-COMET. BMC Cancer. 2024 Feb 3;24(1):171. doi: 10.1186/s12885-024-11905-7.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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
- SIMPLIFY-SABR-COMET
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
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