Evidence map›Paper›PMID 30157910›Full record

Trial reportTrials2018

Zoledronic acid in the management of mesothelioma - a feasibility study (Zol-A Trial): study protocol for a randomised controlled trial.

Duneesha de Fonseka, Anna Morley, Louise Stadon, Emma Keenan, Steven Walker, Sarah Smith, John E Harvey, R Ashley Cox, Adam Dangoor, Charles Comins and 4 more

Open access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 26% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 7 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

14 authors at 5 institutions in 1 country.

Duneesha de FonsekaAcademic Respiratory Unit, University of Bristol, Bristol, UK. duneesha@gmail.com.ORCID http://orcid.org/0000-0002-0060-9671
Anna MorleyRespiratory Research Unit, North Bristol NHS Trust, Bristol, UK.
Louise StadonRespiratory Research Unit, North Bristol NHS Trust, Bristol, UK.
Emma KeenanRespiratory Research Unit, North Bristol NHS Trust, Bristol, UK.
Steven WalkerAcademic Respiratory Unit, University of Bristol, Bristol, UK.
Sarah SmithNorth Bristol NHS Trust, Bristol, UK.
John E HarveyAcademic Respiratory Unit, University of Bristol, Bristol, UK.
R Ashley CoxRoyal United Hospitals Bath NHS Foundation Trust, Bath, UK.
Adam DangoorBristol Haematology and Oncology Centre, Bristol Royal Infirmary, Bristol, UK.
Charles CominsBristol Haematology and Oncology Centre, Bristol Royal Infirmary, Bristol, UK.
Christine RogersClinical Trials and Evaluation Unit, Bristol, UK.
Anthony EdeyRadiology Department, North Bristol NHS Trust, Bristol, UK.
Alfredo AddeoBristol Haematology and Oncology Centre, Bristol Royal Infirmary, Bristol, UK.
Nick A MaskellAcademic Respiratory Unit, University of Bristol, Bristol, UK.
North Bristol NHS Trust · GBUniversity of Bristol · GBBristol Royal Infirmary · GBNIHR Evaluation Trials and Studies Coordinating Centre · GBRoyal United Hospital Bath NHS Trust · GB

Funding

Department of Health PB-PG-1014-35052Research for Patient Benefit Programme PB-PG-1014-35052
6 · The paper itself

Abstract

backgroundNitrogen containing bisphosphonates such as zoledronic acid (ZA) are known to contain certain anti-cancer properties. These have been investigated in the past in various cancers such as breast, prostate and colon. ZA in particular has shown promising results in pre-clinical studies. We propose a multicentre double-blind randomised controlled feasibility study to assess the recruitment and acceptability of ZA/placebo alongside chemotherapy in malignant pleural mesothelioma (MPM).

methodsPatients will be recruited for a 13-month period from October 2016 to November 2017. Eligible patients will be identified via the regional mesothelioma multidisciplinary team meeting. Those who receive chemotherapy will be randomised to receive either ZA or placebo alongside their chemotherapy. Those who decline chemotherapy will be offered to join the trial on the non-randomised open-labelled arm of the trial. Patients will receive a maximum of six cycles of ZA/placebo, at three-weekly cycles. All patients will be followed up for six months from randomisation. Semi-structured interviews to gather data on acceptability of trial procedures, tolerability of ZA and other relevant information will take place after the participants have completed their six cycles of treatment. For a better understanding about non-participation in mesothelioma trials we also aim to interview those who decline to take part in the trial. DISCUSSION: The qualitative and quantitative data gathered in this feasibility trial will hopefully pave the way to designing a robust full phase III trial to investigate the potential synergistic effect of ZA and current standard treatment for MPM, cisplatin-pemetrexed combination chemotherapy.

trial registrationISRCTN Registry, ISRCTN45536692 . Registered on 9 August 2016. EudraCT no. 2015-004433-26.

Indexed as

Antineoplastic Combined Chemotherapy ProtocolsMesotheliomaPleural NeoplasmsZoledronic AcidCisplatinDouble-Blind MethodEnglandFeasibility StudiesHumansPemetrexedResearch DesignTime FactorsTreatment OutcomeCisplatinPemetrexedZoledronic AcidMalignant pleural mesotheliomaMesothelinMesotheliomaPET-CTZoledronic acid

Identifiers

PMID30157910
PMCPMC6116562
OpenAlexW2889416059

What OpenQuestion holds

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Registered trials

None linked

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.