Evidence map›Paper›PMID 31783816›Full record

ArticleBMC cancer2019

Radiotherapy for metastatic spinal cord compression with increased radiation doses (RAMSES-01): a prospective multicenter study.

Dirk Rades, Olfred Hansen, Lars Henrik Jensen, Liesa Dziggel, Christian Staackmann, Claudia Doemer, Jon Cacicedo, Antonio J Conde-Moreno, Barbara Segedin, Raquel Ciervide-Jurio and 11 more

Registry-linked trialAbstract read
In one paragraph

Article in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04043156 (RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES), 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.

NCT04043156 naterminatednot on this map

RAdiotherapy for Metastatic Spinal Cord Compression with Increased Radiation DosES

TypeinterventionalSponsorUniversity Hospital Schleswig-HolsteinRan2019 to 2023Enrolled52ConditionsSpinal Cord Compression Due to Metastasis to SpineArmsHigh-precision RT
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

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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

21 authors.

Dirk RadesDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. Rades.Dirk@gmx.net.
Olfred HansenDepartment of Oncology, Odense University Hospital, Odense, Denmark.
Lars Henrik JensenDepartment of Oncology, University of Southern Denmark, Vejle, Denmark.
Liesa DziggelDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
Christian StaackmannDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
Claudia DoemerDepartment of Radiation Oncology, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany.
Jon CacicedoDepartment of Radiation Oncology, Cruces University Hospital, Barakaldo, Vizcaya, Spain.
Antonio J Conde-MorenoDepartment of Radiation Oncology, University and Polytechnic Hospital La Fe, Valencia, Spain.
Barbara SegedinDepartment of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia.
Raquel Ciervide-JurioDepartment of Radiation Oncology, University Hospital HM Sanchinarro, Madrid, Spain.
Carmen Rubio-RodriguezDepartment of Radiation Oncology, University Hospital HM Sanchinarro, Madrid, Spain.
Luis A Perez-RomasantaDepartment of Radiation Oncology, University Hospital Salamanca, Salamanca, Spain.
Ana Alvarez-GraciaDepartment of Radiation Oncology, ICO - University Hospital Germans Trias i Pujol, Badalona, Spain.
Kristopher DennisDivision of Radiation Oncology, The Ottawa Hospital & University of Ottawa, Ottawa, Canada.
Carlos Ferrer-AlbiachDepartment of Radiation Oncology, Consorcio Hospital Provincial de Castellón, Castellón, Spain.
Arturo Navarro-MartinDepartment of Radiation Oncology, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona, Spain.
Fernando Lopez-CamposDepartment of Radiation Oncology, University Hospital Ramón y Cajal, Madrid, Spain.
Natalia JankarashviliDepartment of Radiation Oncology, F. Todua Medical Center, Tbilisi, Georgia.
Stefan JanssenMedical Practice for Radiotherapy and Radiation Oncology, Hannover, Germany.
Denise OlbrichCentre for Clinical Trials Lübeck, Lübeck, Germany.
Niels Henrik HolländerDepartment of Oncology and Palliative Units, Zealand University Hospital, Naestved, Denmark.

Funding

Interreg 094 -1.1-18
6 · The paper itself

Abstract

backgroundPatients with metastatic spinal cord compression (MSCC) and favorable survival prognoses can benefit from radiation doses greater than 30Gy in 10 fractions in terms of improved local progression-free survival (LPFS) and overall survival (OS). METHODS/

designThis prospective study mainly investigates LPFS after precision radiotherapy (volumetric modulated arc therapy or stereotactic body radiotherapy) with 18 × 2.33Gy in 3.5 weeks. LPFS is defined as freedom from progression of motor deficits during radiotherapy and an in-field recurrence of MSCC following radiotherapy. The maximum relative dose allowed to the spinal cord is 101.5% of the prescribed dose, resulting in an equivalent dose in 2Gy-fractions (EQD2) for radiation myelopathy is 45.5Gy, which is below the tolerance dose of 50Gy according to the Quantitative Analyses of Normal Tissue Effects in the Clinic (QUANTEC). The EQD2 of this regimen for tumor cell kill is 43.1Gy, which is 33% higher than for 30Gy in 10 fractions (EQD2 = 32.5Gy). Primary endpoint is LPFS at 12 months after radiotherapy. Secondary endpoints include the effect of 18 × 2.33Gy on motor function, ambulatory status, sensory function, sphincter dysfunction, LPFS at other follow-up times, overall survival, pain relief, relief of distress and toxicity. Follow-up visits for all endpoints will be performed directly and at 1, 3, 6, 9 and 12 months after radiotherapy. A total of 65 patients are required for the prospective part of the study. These patients will be compared to a historical control group of at least 235 patients receiving conventional radiotherapy with 10x3Gy in 2 weeks. DISCUSSION: If precision radiotherapy with 18 × 2.33Gy results in significantly better LPFS than 10x3Gy of conventional radiotherapy, this regimen should be strongly considered for patients with MSCC and favorable survival prognoses.

trial registrationClinicaltrials.gov NCT04043156. Registered 30-07-2019.

Indexed as

Dose Fractionation, RadiationClinical Trials as TopicDose-Response Relationship, RadiationHumansRadiation InjuriesRadiosurgeryRadiotherapy, Intensity-ModulatedSpinal Cord CompressionSpinal NeoplasmsSurvival AnalysisFavorable survival prognosisIncreased radiation doseLocal progression-free survivalMetastatic spinal cord compressionPrecision radiotherapy

Identifiers

PMID31783816
PMCPMC6884857

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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.