Evidence map›Paper›PMID 36750848›Full record

Trial reportRadiation oncology (London, England)2023

Radiosurgery of limited brain metastases from primary solid tumor: results of the randomized phase III trial (NCT02355613) comparing treatments executed with a specialized or a C-arm linac-based platform.

Marta Scorsetti, Pierina Navarria, Luca Cozzi, Elena Clerici, Luisa Bellu, Davide Franceschini, Antonio Marco Marzo, Ciro Franzese, Valter Torri, Giacomo Reggiori and 7 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in Radiation oncology (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02355613 (Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 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.

NCT02355613 nacompletednot on this map

Comparative Evaluation of Two Different Radiosurgery Modalities in Brain Metastatic Patients From Several Solid Tumors

TypeinterventionalSponsorIstituto Clinico HumanitasRan2014 to 2021Enrolled250ConditionsMetastases to BrainArmsRadiosurgery with Gamma Knife Perfexion, Linac-based Radiosurgery with EDGE
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

17 authors.

Marta ScorsettiRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Pierina NavarriaRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy. pierina.navarria@humanitas.it.
Luca CozziRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Elena ClericiRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Luisa BelluRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Davide FranceschiniRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Antonio Marco MarzoRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Ciro FranzeseRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Valter TorriOncology Department, IRCCS Istituto Mario Negri, Milan, Italy.
Giacomo ReggioriRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Francesca LobefaloRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Luca RaspagliesiNeurosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Luca AttuatiNeurosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Federico PessinaRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.
Andrea FranziniNeurosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Piero PicozziNeurosurgery Department, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy.
Stefano TomatisRadiotherapy and Radiosurgery Department, IRCCS Humanitas Research Hospital, Via Manzoni 56, 20089, Rozzano, Milan, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundComparative prospective data regarding different radiosurgery (SRS) modalities for treating brain metastases (BMs) from solid tumors are not available. To investigate with a single institute phase III randomized trial whether SRS executed with linac (Arm-B) is superior to a dedicated multi-source gamma-ray stereotactic platform (Arm-A).

methodsAdults patients with 1-4 BMs from solid tumors up to 30 mm in maximum diameter were randomly assigned to arms A and B. The primary endpoint was cumulative incidence of symptomatic (grade 2-3) radionecrosis (CIRN). Secondary endpoints were local progression cumulative incidence (CILP), distant brain failure, disease-free survival (DFS), and overall survival (OS).

resultsA total of 251 patients were randomly assigned to Arm-A (121) or Arm-B (130). The 1-year RN cumulative incidence was 6.7% in whole cohort, 3.8% (95% CI 1.9-7.4%) in Arm-B, and 9.3% (95% CI 6.2-13.8%) in the Arm-A (p = 0.43). CIRN was influenced by target volume irradiated only for the Arm-A (p << 0.001; HR 1.36 [95% CI 1.25-1.48]). Symptomatic RN occurred in 56 cases at a median time of 10.3 months (range 1.15-54.8 months), 27 in the Arm-B at a median time of 15.9 months (range 4.9-54.8 months), and 29 in the Arm-A at a median time of 6.9 months (1.2-32.3 months), without statistically significant differences between the two arms. No statistically significant differences were recorded between the two arms in CILP, BDF, DFS or OS. The mean beam-on time to deliver SRS was 49.0 ± 36.2 min in Arm-A, and 3.1 ± 1.6 min in Arm-B.

conclusionsGiven the technical differences between the treatment platforms investigated in this single-institution study, linac-based SRS (Arm-B) did not lead to significantly lower grade 2-3 RN rates versus the multi-source gamma-ray system (Arm-A) in a population of patients with limited brain metastases of small volume. No significant difference in local control was observed between both arms. For Arm-B, the treatment delivery time was significantly lower than for Arm-A.

trial registrationClinicalTrials.gov Identifier NCT02355613.

Indexed as

Brain NeoplasmsRadiosurgeryAdultHumansProgression-Free SurvivalProspective StudiesRetrospective StudiesTreatment OutcomeBrain metastasesGamma Knife-radiosurgeryLinac-based radiosurgeryRadionecrosisRadiosurgeryRandomized phase 3 trial

Identifiers

PMID36750848
PMCPMC9906937

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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.