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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 8 August 2016
Main ID:  EUCTR2015-004433-26-GB
Date of registration: 17/03/2016
Prospective Registration: Yes
Primary sponsor: North Bristol NHS Trust
Public title: Zoledronic acid in the management of Mesothelioma - a feasibility trial
Scientific title: Zoledronic acid in the management of malignant pleural mesothelioma - a feasibility study - ZOL-A trial
Date of first enrolment: 04/05/2016
Target sample size: 70
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004433-26
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: yes Other trial design description: Open label third arm for those not having concurrent chemotherapy If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
United Kingdom
Contacts
Name: Duneesha de Fonseka   
Address:  Learning and Reasearch Building, Level 2, Southmead Hospital BS10 5NB Bristol United Kingdom
Telephone: 01174148041
Email: duneesha.defonseka@nbt.nhs.uk
Affiliation:  North Bristol NHS Trust
Name: Duneesha de Fonseka   
Address:  Learning and Reasearch Building, Level 2, Southmead Hospital BS10 5NB Bristol United Kingdom
Telephone: 01174148041
Email: duneesha.defonseka@nbt.nhs.uk
Affiliation:  North Bristol NHS Trust
Key inclusion & exclusion criteria
Inclusion criteria:
-Histo-cytologically confirmed diagnosis of MPM
-WHO performance status 0-1
-Eligible for first line chemotherapy treatment
-Measurable disease on CT as per modified RECIST criteria (tumour thickness >5mm)
-Ability to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion criteria:
Not fit for chemotherapy due to performance status or other comorbidities
Previous chemotherapy for MPM
IV bisphosphonates in the 3 months preceding randomisation
Significant renal disease (eGFR < 30ml/min in the last 4 weeks)
Hypocalcaemia (current hypocalcaemia on treatment, evidence of hypocalcaemia on most recent blood tests – should be within the last 6 weeks)
Known allergy to bisphosphonates or excipients of its preparation
Severe untreated dental caries
Concomitant participation in another drug trial for mesothelioma
Allergy to 18-Fluodeoxyglucose used for the PET scan
Women of child bearing potential (defined as fertile, or following menarche and until becoming post-menopausal unless permanently sterile)



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Malignant pleural mesothelioma
MedDRA version: 19.0 Level: PT Classification code 10027406 Term: Mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0 Level: PT Classification code 10035603 Term: Pleural mesothelioma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0 Level: PT Classification code 10059518 Term: Pleural mesothelioma malignant System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]
Intervention(s)

Trade Name: Zometa 4 mg/5 ml concentrate for solution for infusion
Product Name: Zoledronic acid
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Zoledronic acid
CAS Number: 118072-93-8
Other descriptive name: Zoledronic acid monohydrate
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 4mg-in 5ml
Pharmaceutical form of the placebo: Infusion
Route of administration of the placebo: Intravenous use

Primary Outcome(s)
Main Objective: As this is a feasibility study there are no primary or secondary objectives to the trial. The overarching question is whether it would be feasible to run a full trial to determine if the addition of Zoledronic acid to 1st line chemotherapy would confer a further benefit to patients with mesothelioma, with regards to survival.
The feasibility of this trial will be assessed along the following criteria:
1. Feasibility of randomising 50 patients in 12 months
2. Acceptability of recruitment procedures, consent and randomisation, and data collection methods.
3. Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration.
4. Qualitative assessment in a subgroup of 10 patients (from the randomised and non-randomised groups) to evaluate patients' experience in the randomisation and/or recruitment process
5. Quantification of drop-out and data completeness rates
6. Estimates of outcome event rates eg. survival times, measures of mean response and outco
Primary end point(s): As this is a feasibility trial,the feasibility assessments will be along the points below:

1. Feasibility of randomising 50 patients over a 12 month period
2. Acceptability of recruitment procedures, consent and randomisation, and data collection methods.
3. Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration.
4. Qualitative assessment in a subgroup of 10 patients to evaluate patients' experience in the randomisation and recruitment process
5. Quantification of drop-out and data completeness rates
6. Estimates of outcome event rates eg. survival times, measures of mean response and outcome variance (continuous variables such as quality of life) and confidence intervals around estimates of proportions, categorical variables such as recruitment rates)to use for calculating full trial size and number of sites.
Secondary Objective: If this trial proves that it is feasible to run an appropriately statistically powered trial, the outcomes we would be looking for are as below:

• Proportion of patients with progression free survival at 6 months
• Time to progression
• Overall survival from randomisation
• Progression free survival from randomisation
• Rate of progression of MPM, as measured by modified RECIST criteria on CT, after 3 cycles of chemotherapy (Pemetrexed/Cisplatin)
• Rate of progression in MPM, as measured by modified RECIST criteria on CT, after 6 cycles of chemotherapy.
• Tumour metabolic activity as determined by Total glycolytic volume (TGV) on PET-CT scans, after 3 cycles of chemotherapy
• Value of TGV or standard uptake value (SUV) in the assessment of disease response/progression
• Serum mesothelin as a useful biomarker for monitoring disease and detecting treatment response
• Quality of life determined by dyspnoea Visual analogue scale (VAS) scores and EQ5D
Timepoint(s) of evaluation of this end point: Following completion of 6 months of follow-up for all recruited patients
Secondary Outcome(s)
Secondary end point(s): -Acceptability of recruitment procedures, consent and randomisation, and data collection methods.
-Acceptability of ZA in MPM patients, and the optimal timing and location for ZA administration.
-Qualitative assessment in a subgroup of 10 patients to evaluate patients experience in the randomisation and recruitment process
-Quantification of drop-out and data completeness rates
-Estimates of outcome event rates eg. survival times, measures of mean response and outcome variance (continuous variables such as quality of life) and confidence intervals around estimates of proportions, categorical variables such as recruitment rates)to use for calculation of full trial size and number of recruitment centres
Secondary ID(s)
3638
Source(s) of Monetary Support
NIHR - RfPB funding
Secondary Sponsor(s)
Results
Results available:
Date Posted:
URL:
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