Main
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Note: This record shows only 22 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:
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EUCTR |
Last refreshed on:
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28 February 2019 |
Main ID: |
EUCTR2015-004433-26-GB |
Date of registration:
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17/03/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Zoledronic acid in the management of Mesothelioma - a feasibility trial
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Scientific title:
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Zoledronic acid in the management of malignant pleural mesothelioma - a feasibility study - ZOL-A trial |
Date of first enrolment:
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04/05/2016 |
Target sample size:
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70 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004433-26 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Duneesha de Fonseka
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Address:
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Learning and Reasearch Building, Level 2, Southmead Hospital
BS10 5NB
Bristol
United Kingdom |
Telephone:
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01174148041 |
Email:
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duneesha.defonseka@nbt.nhs.uk |
Affiliation:
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North Bristol NHS Trust |
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Name:
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Duneesha de Fonseka
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Address:
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Learning and Reasearch Building, Level 2, Southmead Hospital
BS10 5NB
Bristol
United Kingdom |
Telephone:
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01174148041 |
Email:
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duneesha.defonseka@nbt.nhs.uk |
Affiliation:
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North Bristol NHS Trust |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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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
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Primary Outcome(s)
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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.
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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
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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
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Timepoint(s) of evaluation of this end point: Following completion of 6 months of follow-up for all recruited patients
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Secondary Outcome(s)
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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
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Source(s) of Monetary Support
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NIHR - RfPB funding
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Ethics review
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Status: Approved
Approval date:
Contact:
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