Evidence map›Paper›PMID 31072314›Full record

ArticleBMC cancer2019

Combined kyphoplasty and intraoperative radiotherapy (Kypho-IORT) versus external beam radiotherapy (EBRT) for painful vertebral metastases - a randomized phase III study.

Frederic Bludau, Grit Welzel, Tina Reis, Yasser Abo-Madyan, Elena Sperk, Frank Schneider, Sven Clausen, Arne M Ruder, Udo Obertacke, Maged M Ghaly and 2 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
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 NCT02773966 (Intraoperative Radiotherapy During Kyphoplasty/Vertebroplasty), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.5field-weighted citation impact, top 18% 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.

NCT02773966 phase3terminatednot on this map

Intraoperative Radiotherapy During Kyphoplasty/Vertebroplasty (Kypho-IORT) Versus EBRT in the Treatment of Painful Vertebral Metastases - a Randomized Prospective Phase III Study -

TypeinterventionalSponsorUniversitätsmedizin MannheimRan2017 to 2020Enrolled6ConditionsMetastasisArmsKypho-IORT, EBRT
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 11 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
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 at 4 institutions in 2 countries.

Frederic BludauDepartment of Orthopaedic and Trauma Surgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
Grit WelzelDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Tina ReisDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Yasser Abo-MadyanDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Elena SperkDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Frank SchneiderDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Sven ClausenDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Arne M RuderDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Udo ObertackeDepartment of Orthopaedic and Trauma Surgery, University Medical Center Mannheim, University of Heidelberg, Mannheim, Germany.
Maged M GhalyDepartment of Radiation Medicine, Northwell Health Physician Partners, Hofstra Northwell School of Medicine, Lake Success, NY, USA.
Frederik WenzDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany.
Frank A GiordanoDepartment of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany. frank.giordano@umm.de.
University Medical Centre Mannheim · DEHeidelberg University · DENorthwell Health · USUniversity Hospital Heidelberg · DE

Funding

Carl Zeiss Meditec AG Unrestricted Grant
6 · The paper itself

Abstract

backgroundThe spine is the most frequent location of bone metastases. Local treatment aims at palliation of pain and, given the increased likelihood of long-term cancer survival, at local control. Kyphoplasty and intraoperative radiotherapy (Kypho-IORT) provided instantaneous pain relief in 70% of patients at the first day after the intervention and resulted in local control rates of > 93% at 1 year in a recently conducted phase I/II trial. To assess its clinical value, we designed a phase III trial which tests Kypho-IORT against the most widespread standard-of-care, external beam radiotherapy (EBRT), in patients with painful vertebral metastases.

methodsThis phase III study includes patients ≥50 years of age with up to 4 vertebral metastases and a pain score of at least 3/10 points on the visual/numeric analogy scale (VAS). Patients randomized into the experimental arm (A) will undergo Kypho-IORT (Kyphoplasty plus IORT with 8 Gy prescribed to 13 mm depth). Patients randomized into the control arm (B) will receive EBRT with either 30 Gy in 10 fractions or 8 Gy as a single dose. The primary end point is pain reduction defined as at least - 3 points on the VAS compared to baseline at day 1. Assuming that 40% of patients in the Kypho-IORT arm and 5% of patients in the control arm will achieve this reduction and 20% will drop out, a total of 54 patients will have to be included to reach a power of 0.817 with a two-sided alpha of 0.05. Secondary endpoints are evaluation of the percentage of patients with a pain reduction of at least 3 points at 2 and 6 weeks, local tumor control, frequency of re-intervention, secondary fractures/sintering, complication rates, skin toxicity/wound healing, progression-free survival (PFS), overall survival (OS) and quality of life. DISCUSSION: This trial will generate level 1 evidence on the clinical value of a one-stop procedure which may provide instantaneous pain relief, long-term control and shortened intervals to further adjuvant (systemic) therapies in patients with spinal metastases.

trial registrationRegistered with ClinicalTrials.gov, number: NCT02773966 (Registration date: 05/16/2016).

Indexed as

Cancer PainClinical Trials, Phase III as TopicCombined Modality TherapyDose Fractionation, RadiationHumansIntraoperative CareKyphoplastyMiddle AgedPain ManagementPain MeasurementProgression-Free SurvivalQuality of LifeRandomized Controlled Trials as TopicSpinal NeoplasmsSpineCement augmentationExternal beam radiotherapyIntraoperative radiotherapyKypho-IORTKyphoplastyVertebral metastases

Identifiers

PMID31072314
PMCPMC6507138
OpenAlexW2947031723

What OpenQuestion holds

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LicenceCC BY
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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.