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01.12.2018 | Study protocol | Ausgabe 1/2018 Open Access

Trials 1/2018

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

Zeitschrift:
Trials > Ausgabe 1/2018
Autoren:
Duneesha de Fonseka, Anna Morley, Louise Stadon, Emma Keenan, Steven Walker, Sarah Smith, John E. Harvey, R. Ashley Cox, Adam Dangoor, Charles Comins, Christine Rogers, Anthony Edey, Alfredo Addeo, Nick A. Maskell
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s13063-018-2851-9) contains supplementary material, which is available to authorized users.

Abstract

Background

Nitrogen 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).

Methods

Patients 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 registration

ISRCTN Registry, ISRCTN45536692. Registered on 9 August 2016. EudraCT no. 2015–004433-26.
Zusatzmaterial
Additional file 1: Study visit schedule. (DOCX 160 kb)
13063_2018_2851_MOESM1_ESM.docx
Additional file 2: SPIRIT 2013 Checklist: Recommended items to address in a clinical trial protocol and related documents*. (DOC 122 kb)
13063_2018_2851_MOESM2_ESM.doc
Literatur
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