Onderhoudsbehandeling met gemcitabine bij patiënten met longvlieskanker bij wie de tumor niet groeit na de eerste lijn chemotherapie met een pemetrexed –platinum combinatie. Een gerandomiseerde fase II studie.
Completed
- Conditions
- Malignant pleural mesotheliomaBorstvlieskanker
- Registration Number
- NL-OMON26963
- Lead Sponsor
- Stichting NVALT studies
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 124
Inclusion Criteria
• Patients with histologically or cytologically proven malignant mesothelioma
• Age >18 years.
Exclusion Criteria
• Active uncontrolled infection or severe cardiac dysfunction (such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina).
• Presence of symptomatic CNS metastases.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival, defined as time from randomisation to disease progression or death (in case no progression has been documented)
- Secondary Outcome Measures
Name Time Method - Adverse events<br /><br>- Objective radiological response rate in patients with measurable disease<br /><br>- Overall survival<br /><br>- Changes in vital capacity and FEV1.