Evidence map›Paper›PMID 28938918›Full record

ArticleRadiation oncology (London, England)2017

Combined high dose radiation and pazopanib in metastatic renal cell carcinoma: a phase I dose escalation trial.

Katrien De Wolf, Sylvie Rottey, Karim Vermaelen, Karel Decaestecker, Nora Sundahl, Lizzy De Lobel, Els Goetghebeur, Gert De Meerleer, Nicolaas Lumen, Valérie Fonteyne and 2 more

Registry-linked trialAbstract readClinical Trial, Phase I
PubMed Full text at PMC Publisher
In one paragraph

Article in Radiation oncology (London, England), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02334709 (Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma), which is not on this map. Cited by 14 papers.

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

NCT02334709 phase1 / phase2completednot on this map

Phase I/II Trial of Stereotactic Body Radiotherapy With Concurrent Fixed Dose Tyrosine Kinase Inhibitors in Metastatic Renal Cell Carcinoma: Dose Limiting Toxicity and Abscopal Effect.

TypeinterventionalSponsorUniversity Hospital, GhentRan2014 to 2016Enrolled13ConditionsCarcinoma, Renal CellArmsStereotactic body radiotherapy
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

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  13. Novel Insights for Inhibiting Mutant Heterodimer IDH1Molecular diagnosis & therapy · 2018
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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

12 authors.

Katrien De WolfDepartment of Radiation-Oncology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium.
Sylvie RotteyDepartment of Medical Oncology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium.
Karim VermaelenImmuno-Oncology Network Ghent (ION Ghent), Ghent, Belgium.
Karel DecaesteckerDepartment of Urology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium.
Nora SundahlDepartment of Radiation-Oncology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium.
Lizzy De LobelDepartment of Applied Mathematics, Computer Science and Statistics Ghent University, Ghent, Belgium.
Els GoetghebeurDepartment of Applied Mathematics, Computer Science and Statistics Ghent University, Ghent, Belgium.
Gert De MeerleerDepartment of Radiation-Oncology, University Hospital Leuven, Herestraat 49, 3000, Leuven, Belgium.
Nicolaas LumenCancer Research Institute Ghent (CRIG Ghent), Ghent, Belgium.
Valérie FonteyneDepartment of Radiation-Oncology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium.
Daan De MaeseneerDepartment of Medical Oncology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium.
Piet OstDepartment of Radiation-Oncology, University Hospital Ghent, De Pintelaan 185, 9000, Ghent, Belgium. piet.ost@ugent.be.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe primary objective was to determine maximum tolerated radiation dose in patients with metastatic renal cell carcinoma on pazopanib treatment.

methodsTreatment-naïve patients received pazopanib according to standard of care. Stereotactic body radiotherapy (SBRT) was delivered concurrently to the largest metastatic lesion at day 8, 10 and 12. SBRT doses were escalated in 3 dose levels (24 Gy/3, 30 Gy/3 and 36 Gy/3). Dose level was assigned using Time-to-Event Continual Reassessment Method with the target dose-limiting toxicity rate set to 0.25.

resultsThirteen patients were included. One patient experienced dose limiting toxicity (DLT) at dose level 3 (grade 4 hypoglycemia). Maximum tolerated dose was not reached with a recommended dose of 36 Gy/3 having a probability of DLT of 11%. One-year local control was 83% (95% confidence interval 61-100) and 1-year progression-free survival was 28% (95% confidence interval 1-55).

conclusionsSBRT in combination with pazopanib is well tolerated with good local control and response rates outside the radiation field.

trial registrationThis trial was retrospectively registered on clinicaltrials.gov( NCT02334709 ) on January 6th, 2015.

Indexed as

AgedAngiogenesis InhibitorsAntineoplastic AgentsCarcinoma, Renal CellChemoradiotherapyDisease-Free SurvivalFemaleHumansIndazolesKidney NeoplasmsMaleMaximum Tolerated DoseMiddle AgedNeoplasm MetastasisPyrimidinesRadiosurgeryAngiogenesis InhibitorsAntineoplastic AgentsIndazolespazopanibPyrimidinesSulfonamidesImmune monitoringRenal cell carcinomaStereotactic body radiotherapyTyrosine kinase inhibitors

Identifiers

PMID28938918
PMCPMC5610443

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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.