Evidence map›Paper›PMID 41056433›Full record

Trial reportNeuro-oncology2026

Radiation therapy alone versus radiation therapy plus radiofrequency ablation/vertebral augmentation for painful spine metastasis: A phase 2 randomized controlled trial.

Rupesh Kotecha, Omer Gal, Haley Appel, Maria Carolina Avendano, Antoinette M Pimentel, Amy K Starosciak, Muni Rubens, Mukesh Roy, Dilanis Perche, Cristina I Pow-Sang and 8 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialComparative Study
In one paragraph

Trial report in Neuro-oncology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04375891 (Randomized Phase II Study of Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT04375891 naactive not recruitingnot on this map

Randomized Phase II Study of Radiation Therapy Alone Versus Radiation Therapy Plus Radiofrequency Ablation (RFA)/Vertebral Augmentation for Localized Spine Metastasis

TypeinterventionalSponsorBaptist Health South FloridaRan2020 to 2027Enrolled63ConditionsOncology, Spine MetastasesArmsRadiation Therapy, Radiofrequency Ablation (RFA)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Review
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

18 authors.

Rupesh KotechaDepartment of Radiation Oncology, Miami Cancer Institute, Miami, FL, United States.ORCID 0000-0001-6927-0402
Omer GalDepartment of Radiation Oncology, Miami Cancer Institute, Miami, FL, United States.
Haley AppelDepartment of Radiation Oncology, Miami Cancer Institute, Miami, FL, United States.
Maria Carolina Avendano; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Antoinette M Pimentel; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Amy K Starosciak; Herbert Wertheim College of Medicine, Florida International University, Miami, FL, United States.
Muni Rubens; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Mukesh Roy; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Dilanis Perche; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Cristina I Pow-Sang; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Fabiana Milosevic; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Ramon F Cruz; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Alex Kudryashev; Office of Clinical Research, Miami Cancer Institute, Miami, FL, United States.
Matthew D HallDepartment of Radiation Oncology, Miami Cancer Institute, Miami, FL, United States.
Ana BoteroDepartment of Radiation Oncology, Miami Cancer Institute, Miami, FL, United States.
Minesh P MehtaDepartment of Radiation Oncology, Miami Cancer Institute, Miami, FL, United States.ORCID 0000-0002-4812-5713
Justin M Sporrer; Department of Neurosurgery, Miami Neuroscience Institute, Miami, FL, United States.
Brian J Schiro; Herbert Wertheim College of Medicine, Florida International University, Miami, FL, United States.

Funding

Medtronic Inc 2018-KOT-001
6 · The paper itself

Abstract

backgroundRadiation therapy (RT) offers pain relief for patients with symptomatic spine metastases. This study compares pain response and quality of life (QOL) between conventional RT or RT and radiofrequency ablation/percutaneous vertebral augmentation (RFA/PVA).

methodsThis single-center, prospective, randomized phase 2 trial (NCT04375891) enrolled patients with spine metastasis (T5-L5, with 1-2 index sites amenable to RFA) and a minimum Numeric Pain Rating Scale (NPRS) of 5. After stratifying by tumor type (radioresistant vs. radiosensitive), patients were randomized (1:2) to RT or RT+RFA/PVA. The primary endpoint was 3-month pain response. Secondary endpoints included rapidity and duration of pain response, adverse events, and QOL measures.

resultsThe study terminated after enrolling and randomizing 63 patients (79% of planned accrual; 21 RT alone, 42 RT+RFA/PVA). The median baseline NPRS was 10 (interquartile range [IQR] 8-10) for RT and 9 (7.5-10) for RT+RFA/PVA. The primary endpoint of pain control 3 months after treatment was similar between the RT and RT+RFA/PVA arms (50% vs. 48%, P = .92). Complete pain response rates at 3 months were also similar in the RT and RT+RFA/PVA arms (17% vs. 21%, P = .77). The 3-month median NPRS reduction was -4 (IQR, -6 to -1) in both the RT and the RT+RFA/PVA arms. Secondary efficacy endpoints and toxicity rates were comparable. Overall QOL measures including FACT-G, BPI, and EQ-5D scores were also similar between the two treatment arms.

conclusionsThe addition of RFA/PVA to conventional RT for patients with symptomatic spine metastases did not improve pain control or QOL measures at 3 months.

Indexed as

Cancer PainPain ManagementRadiofrequency AblationRadiotherapySpinal NeoplasmsVertebroplastyAdultAgedCombined Modality TherapyFemaleFollow-Up StudiesHumansMaleMiddle AgedPain MeasurementPrognosispalliationradiofrequency ablationradiotherapyspine metastasistrial

Identifiers

PMID41056433
PMCPMC12962626

What OpenQuestion holds

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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.