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Clinical Trials/ISRCTN45536692
ISRCTN45536692
Completed
未知

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

orth Bristol NHS Trust0 sites22 target enrollmentAugust 9, 2016
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ConditionsSpecialty: Respiratory disorders, Primary sub-specialty: Respiratory disordersUKCRC code/ Disease: Cancer/ Malignant neoplasms of respiratory and intrathoracic organsCancerMalignant neoplasms of respiratory and intrathoracic organs

Overview

Phase
未知
Intervention
Not specified
Conditions
Specialty: Respiratory disorders, Primary sub-specialty: Respiratory disorders
Sponsor
orth Bristol NHS Trust
Enrollment
22
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30157910

Registry
who.int
Start Date
August 9, 2016
End Date
July 24, 2018
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
orth Bristol NHS Trust

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Not specified

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