Evidence map›Paper›PMID 33422612›Full record

Trial reportInternational journal of radiation oncology, biology, physics2021

Phase 3 Multi-Center, Prospective, Randomized Trial Comparing Single-Dose 24 Gy Radiation Therapy to a 3-Fraction SBRT Regimen in the Treatment of Oligometastatic Cancer.

Michael J Zelefsky, Yoshiya Yamada, Carlo Greco, Eric Lis, Heiko Schöder, Stephanie Lobaugh, Zhigang Zhang, Steve Braunstein, Mark H Bilsky, Simon N Powell and 2 more

2 registry-linked trialsAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in International journal of radiation oncology, biology, physics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 57 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
57citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05679427 narecruitingnot on this mapstarted 2022, after this paper: background citation

A Randomised, Prospective, Monoinstitutional Study of Ablative Radiosurgery vs Stereotactic Radiotherapy in 5 Fractions, With Simultaneous Integrated Boost, for the Treatment of Bone Lesions in Oligometastatic Disease

TypeinterventionalSponsorIRCCS San RaffaeleRan2022 to 2027Enrolled307ConditionsOligometastatic DiseaseArmsradiosurgery and stereotactic ablative radiotherapy with simultaneous integrated boost, respectively
NCT05936736 narecruitingnot on this mapstarted 2023, after this paper: background citation

24 Gy in One Fraction Urethral-sparing "High-Dose-Rate Like" Stereotactic Body RadioTherapy for Prostate Cancer: a Single-center Non-randomized Prospective Clinical Study (PRO-FAST)

TypeinterventionalSponsorIRCCS San RaffaeleRan2023 to 2030Enrolled70ConditionsLocalized Prostate CarcinomaArmsprostate SBRT
3 · Its place in the literature

Who cites it

57 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
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  3. SEOR SBRT-SG stereotactic body radiation therapy consensus guidelines for non-spine bone metastasis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Michael J ZelefskyDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: zelefskm@mskcc.org.
Yoshiya YamadaDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Carlo GrecoDepartment of Radiation Oncology, Champalimaud Centre for the Unknown, Lisbon, Portugal.
Eric LisDepartment of Radiology, Memorial Sloan Kettering Cancer Center, New York, New York.
Heiko SchöderDepartment of Radiology, Molecular Imaging and Therapy Service, Memorial Sloan Kettering Cancer Center, New York, New York.
Stephanie LobaughDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Zhigang ZhangDepartment of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.
Steve BraunsteinDepartment of Radiation Oncology, University of California, San Francisco, San Francisco, California.
Mark H BilskyDepartment of Neurosurgery, Memorial Sloan Kettering Cancer Center, New York, New York.
Simon N PowellDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.
Richard KolesnickDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Zvi FuksDepartment of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeThis prospective phase 3 randomized trial was designed to test whether ultra high single-dose radiation therapy (24 Gy SDRT) improves local control of oligometastatic lesions compared to a standard hypofractionated stereotactic body radiation therapy regimen (3 × 9 Gy SBRT). The secondary endpoint was to assess the associated toxicity and the impact of ablation on clinical patterns of metastatic progression. METHODS AND MATERIALS: Between November 2010 and September 2015, 117 patients with 154 oligometastatic lesions (≤5/patient) were randomized in a 1:1 ratio to receive 24 Gy SDRT or 3 × 9 Gy SBRT. Local control within the irradiated field and the state of metastatic spread were assessed by periodic whole-body positron emission tomography/computed tomography and/or magnetic resonance imaging. Median follow-up was 52 months.

resultsA total of 59 patients with 77 lesions were randomized to 24 Gy SDRT and 58 patients with 77 lesions to 3 × 9 Gy SBRT. The cumulative incidence of local recurrence for SDRT-treated lesions was 2.7% (95% confidence interval [CI], 0%-6.5%) and 5.8% (95% CI, 0.2%-11.5%) at years 2 and 3, respectively, compared with 9.1% (95% CI, 2.6%-15.6%) and 22% (95% CI, 11.9%-32.1%) for SBRT-treated lesions (P = .0048). The 2- and 3-year cumulative incidences of distant metastatic progression in the SDRT patients were 5.3% (95% CI, 0%-11.1%), compared with 10.7% (95% CI, 2.5%-18.8%) and 22.5% (95% CI, 11.1%-33.9%), respectively, for the SBRT patients (P = .010). No differences in toxicity were observed.

conclusionsThe study confirms SDRT as a superior ablative treatment, indicating that effective ablation of oligometastatic lesions is associated with significant mitigation of distant metastatic progression.

Indexed as

RadiosurgeryAdultAgedAged, 80 and overDisease ProgressionDose Fractionation, RadiationFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPositron Emission Tomography Computed TomographyProspective StudiesRadiation Dose Hypofractionation

Identifiers

PMID33422612
PMCPMC9472455

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.