Evidence map›Paper›PMID 28464906›Full record

Trial reportBMC cancer2017

Adjuvant radiotherapy after radical cystectomy for patients with muscle invasive bladder cancer: a phase II trial.

Valérie Fonteyne, Piet Dirix, Sara Junius, Elke Rammant, Piet Ost, Gert De Meerleer, Martijn Swimberghe, Karel Decaestecker

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02397434 (Adjuvant Radiotherapy After Cystectomy for Patients With Muscle Invasive Bladder Cancer), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.7field-weighted citation impact, top 27% 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.

NCT02397434 naactive not recruitingnot on this map

Adjuvant Radiotherapy After Cystectomy for Patients With Muscle Invasive Bladder Cancer: a Phase II Trial.

TypeinterventionalSponsorUniversity Hospital, GhentRan2014 to 2028Enrolled76ConditionsToxicityArmsAdjuvant EBRT
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
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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

8 authors at 4 institutions in 1 country.

Valérie FonteyneDepartment of Radiation-Oncology, Ghent University Hospital, De Pintelaan 185, Ghent, Belgium. valerie.fonteyne@uzgent.be.ORCID 0000-0001-6724-1595
Piet DirixDepartment of Radiation-Oncology, Iridium Cancer Network, Ghent, Belgium.
Sara JuniusDepartment of Radiation-Oncology CH-M/AMPR, Mouscron, Belgium.
Elke RammantDepartment of Radiation-Oncology, Ghent University Hospital, De Pintelaan 185, Ghent, Belgium.
Piet OstDepartment of Radiation-Oncology, Ghent University Hospital, De Pintelaan 185, Ghent, Belgium.
Gert De MeerleerDepartment of Radiotherapy and Experimental Cancer Research, Ghent University, Ghent, Belgium.
Martijn SwimbergheDepartment of Radiation-Oncology, Ghent University Hospital, De Pintelaan 185, Ghent, Belgium.
Karel DecaesteckerDepartment of Urology, Ghent University Hospital, Ghent, Belgium.
Ghent University Hospital · BECentre Hospitalier de Mouscron · BEGhent University · BEIridium Kankernetwerk · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundNeo-adjuvant chemotherapy followed by radical cystectomy with extended pelvic lymph node dissection is considered to be the treatment of choice for patients with muscle invasive bladder cancer (MIBC). Despite this aggressive treatment the outcome is poor and ultimately, 30% of the patients with ≥pT3 tumors develop a pelvic recurrence. We hypothesize that postoperative adjuvant external beam radiotherapy (EBRT) might prevent local and lymph node recurrence and improve disease free- and overall survival as loco-regional recurrence is linked to the development of distant metastasis.

methodsWe plan to perform a multicentric prospective phase two study including 76 patients. Eligible patients are patients with MIBC, treated with radical cystectomy and presenting with ≥1 of the following characteristics: Pathological (p)T3 stage + presence of lymphovascular invasion on pathological examination pT4 stage <10 lymph nodes removed positive lymph nodes positive surgical margins Patients will have a DISCUSSION: This is a prospective phase 2 trial re-assessing the feasibility of adjuvant radiotherapy in high-risk MIBC.

trial registrationThe Ethics committee of the Ghent University Hospital (EC2014/0630) approved this study on 31/07/2014. Trial registration on Clinicaltrials.gov ( NCT02397434 ) on November 19, 2014.

Indexed as

AdultCystectomyFemaleHumansMaleProspective StudiesRadiotherapy, AdjuvantUrinary Bladder NeoplasmsMuscle invasive bladder cancer-adjuvant radiotherapy-toxicity

Identifiers

PMID28464906
PMCPMC5414216
OpenAlexW2611039607

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.