Evidence map›Paper›PMID 32002547›Full record

Trial reportNeuro-oncology2020

A phase I/II trial of 5-fraction stereotactic radiosurgery with 5-mm margins with concurrent temozolomide in newly diagnosed glioblastoma: primary outcomes.

Melissa Azoulay, Steven D Chang, Iris C Gibbs, Steven L Hancock, Erqi L Pollom, Griffith R Harsh, John R Adler, Ciara Harraher, Gordon Li, Melanie Hayden Gephart and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neuro-oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06551909 (Radioimmunotherapy in Solid Tumors), which is not on this map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
4.5field-weighted citation impact, top 5% of its field
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.

NCT06551909 narecruitingnot on this mapstarted 2024, after this paper: background citation

Radioimmunotherapy in Solid Tumors (Aim 2- Stereotactic Neoadjuvant Radiotherapy for Glioblastoma)

TypeinterventionalSponsorIRCCS San RaffaeleRan2024 to 2027Enrolled30ConditionsGlioblastomaArmsNeoaddjuvant Stereotactic Radiotherapy with Simultaneous Integrated Boost
3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 61 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 3 institutions in 2 countries.

Melissa AzoulayDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Steven D ChangDepartment of Neurosurgery, Stanford University, Stanford, California, USA.
Iris C GibbsDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Steven L HancockDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Erqi L PollomDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Griffith R HarshDepartment of Neurosurgery, Stanford University, Stanford, California, USA.
John R AdlerDepartment of Neurosurgery, Stanford University, Stanford, California, USA.
Ciara HarraherDepartment of Neurosurgery, Stanford University, Stanford, California, USA.
Gordon LiDepartment of Neurosurgery, Stanford University, Stanford, California, USA.
Melanie Hayden GephartDepartment of Neurosurgery, Stanford University, Stanford, California, USA.
Seema NagpalDepartment of Neurology, Stanford University, Stanford, California, USA.
Reena P ThomasDepartment of Neurology, Stanford University, Stanford, California, USA.
Lawrence D RechtDepartment of Neurology, Stanford University, Stanford, California, USA.
Lisa R JacobsDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Leslie A ModlinDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Jacob WynneDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Kira SeigerDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Dylann FujimotoDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Melissa UsozDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Rie von EybenDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Clara Y H ChoiDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Scott G SoltysDepartment of Radiation Oncology, Stanford University, Stanford, California, USA.
Stanford University · USMcGill University Health Centre · CASanta Clara Valley Medical Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe sought to determine the maximum tolerated dose (MTD) of 5-fraction stereotactic radiosurgery (SRS) with 5-mm margins delivered with concurrent temozolomide in newly diagnosed glioblastoma (GBM).

methodsWe enrolled adult patients with newly diagnosed glioblastoma to 5 days of SRS in a 3 + 3 design on 4 escalating dose levels: 25, 30, 35, and 40 Gy. Dose limiting toxicity (DLT) was defined as Common Terminology Criteria for Adverse Events grades 3-5 acute or late CNS toxicity, including adverse radiation effect (ARE), the imaging correlate of radiation necrosis.

resultsFrom 2010 to 2015, thirty patients were enrolled. The median age was 66 years (range, 51-86 y). The median target volume was 60 cm3 (range, 14.7-137.3 cm3). DLT occurred in 2 patients: one for posttreatment cerebral edema and progressive disease at 3 weeks (grade 4, dose 40 Gy); another patient died 1.5 weeks following SRS from postoperative complications (grade 5, dose 40 Gy). Late grades 1-2 ARE occurred in 8 patients at a median of 7.6 months (range 3.2-12.6 mo). No grades 3-5 ARE occurred. With a median follow-up of 13.8 months (range 1.7-64.4 mo), the median survival times were: progression-free survival, 8.2 months (95% CI: 4.6-10.5); overall survival, 14.8 months (95% CI: 10.9-19.9); O6-methylguanine-DNA methyltransferase hypermethylated, 19.9 months (95% CI: 10.5-33.5) versus 11.3 months (95% CI: 8.9-17.6) for no/unknown hypermethylation (P = 0.03), and 27.2 months (95% CI: 11.2-48.3) if late ARE occurred versus 11.7 months (95% CI: 8.9-17.6) for no ARE (P = 0.08).

conclusionsThe per-protocol MTD of 5-fraction SRS with 5-mm margins with concurrent temozolomide was 40 Gy in 5 fractions. ARE was limited to grades 1-2 and did not statistically impact survival.

Indexed as

Brain NeoplasmsGlioblastomaRadiosurgeryAgedAged, 80 and overAntineoplastic Agents, AlkylatingChemoradiotherapyFemaleHumansMaleMiddle AgedTemozolomideAntineoplastic Agents, AlkylatingTemozolomideglioblastomahypofractionatednewly diagnosedprospectiveradiosurgery

Identifiers

PMID32002547
PMCPMC7594571
OpenAlexW3003700434

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.