Condition category
Cancer
Date applied
27/07/2016
Date assigned
09/08/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Scientific

Primary contact

Dr Emma Keenan

ORCID ID

http://orcid.org/0000-0002-3884-1345

Contact details

Clinical Research Centre - Respiratory
Southmead Hospital
North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom

Type

Scientific

Additional contact

Dr Duneesha de Fonseka

ORCID ID

http://orcid.org/0000-0002-0060-9671

Contact details

Level 2
Learning and Research Building
Southmead Hospital
Bristol
BS10 5NB
United Kingdom
+44 117 4148041
Duneesha.defonseka@nbt.nhs.uk

Additional identifiers

EudraCT number

2015-004433-26

ClinicalTrials.gov number

Protocol/serial number

30497

Study information

Scientific title

A double-blind randomised controlled trial (RCT) to assess the feasibility of giving Zoledronic acid alongside chemotherapy in patients with mesothelioma to design a larger trial to assess the efficacy of Zoledronic acid alongside first line chemotherapy

Acronym

ZOL-A

Study hypothesis

The aim of this study is to investigate the feasibility of running a trial to establish the role of zoledronic acid (ZA) in patients who have mesothelioma and are undergoing or eligible for chemotherapy.

Ethics approval

East of England - Cambridge East Research Ethics Committee, 10/05/2016, ref: 16/EE/0105

Study design

Randomised; Interventional; Design type: Treatment, Drug, Imaging

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders; UKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organs

Intervention

Patients will be randomised using varying block sizes on a 1:1 to one of two groups using web based software developed by Sealed Envelope. Randomisation will be stratified according to histological subtype. Participants will be allocated to either the IMP (Zoledronic acid) or placebo arms.

Participants in both arms of the trial will receive the infusion on the day of their chemotherapy, just prior to start of their chemotherapy treatment. They will have the same number of cycles of the IMP/placebo, as chemotherapy. Those who stop chemotherapy treatment early will stop IMP/placebo treatment too.

A renally adjusted dose of Zoledronic acid or placebo will be administered in 100ml of 0.9% saline via an intravenous cannula over 15 minutes alongside each session of chemotherapy (every 3 weeks, up to a maximum of 6 cycles). Randomised patients will be stratified by histological subtype and allocated to either Zoledronic acid or placebo. A third non-randomised arm of the trial is available to patients who decline chemotherapy but would like an opportunity to have Zoledronic acid on its own (every 3 weeks, up to a maximum of 6 cycles).

Follow up will occur after each cycle, at end of treatment and at 6 months, and involves information gathering on any AEs or SAEs relating to the IMP. Participants will also have blood tests at their follow-up appointments to ensure they are able to continue with the next cycle of chemotherapy treatment/IMP or placebo.

Intervention type

Other

Phase

Drug names

Primary outcome measures

1. Recruitment rate is recorded as the number of eligible participant who consent to participate in the study by 6 months
2. Acceptability of recruitment procedures, consent and randomisation, and data collection methods are measured through patient interviews conducted at 6 months
3. Tolerance of the IMP treatment will be measured by the proportion of patients who complete the full 6 cycles of treatment
4. Intolerance will be recorded for those who are unable to continue to with the IMP due to electrolyte disturbances or AEs relating to the IMP and come off treatment before completing 6 cycles
5. Efficacy data will be measured using CT scans, PET-CT scans and Mesothelin bloods tests. On CT a > 15% reduction in the modified RECIST score would be classed as a disease response. CT will be performed at post 3 cycles and at 6 months from enrolment

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/04/2016

Overall trial end date

31/05/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Histologically confirmed diagnosis of MPM
2. WHO performance status 0-1
3. Eligible for first line chemotherapy treatment Measurable disease on CT as per modified RECIST criteria (tumour thickness > 5mm)
4. Ability to give informed consent
5. Aged 18 years and over

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 70; UK Sample Size: 70

Participant exclusion criteria

1. Not fit for chemotherapy due to performance status or other comorbidities Previous chemotherapy for MPM
2. IV bisphosphonates in the 3 months preceding randomisation
3. Significant renal disease (eGFR < 30ml/min in the last 4 weeks)
4. Hypocalcaemia (current hypocalcaemia on treatment, evidence of hypocalcaemia on most recent blood tests - should be within last 6 weeks)
5. Pregnancy or lactation Age
6. Age < 18 years
7. Known allergy to bisphosphonates or excipients of its preparation
8. Severe untreated dental caries
9. Concomitant participation in another drug trial for mesothelioma

Recruitment start date

01/09/2016

Recruitment end date

31/08/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Clinical Research Centre - Respiratory
Southmead Hospital North Bristol NHS Trust
Bristol
BS10 5NB
United Kingdom

Sponsor information

Organisation

North Bristol NHS Trust

Sponsor details

Research & Innovation
Learning & Research Building
Southmead Hospital
Westbury-on-Trym
Bristol
BS10 5NB
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results will be presented at an international mesothelioma research meeting such as International Mesothelioma interest Group (iMiG) and published in a peer reviewed scientific journal.

Intention to publish date

31/07/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review