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Cisplatin With Either Alimta or Gemcitabine in Long Infusion for Mesothelioma: A Randomised Phase II Trial (AGILI Trial)
This is a randomised Phase II clinical trial to assess and compare efficacy and safety profile of cisplatin and pemetrexed against cisplatin and low-dose gemcitabine in long infusion.
Details
| Lead sponsor | Institute of Oncology Ljubljana |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 72 |
| Start date | 2008-08 |
Conditions
- Mesothelioma
Interventions
- Gemcitabine in long infusion
Primary outcomes
- Progression free survival — CT measurement of disease will be performed after 2nd cycle of chemotherapy, at the end of the treatment and during follow up period up to progression (total average 8 months)
Efficacy of the treatment will be measured by response rate (RR) and progression free survival (PFS) using modified RECIST criteria for assessment of response in malignant pleural mesothelioma
Countries
Slovenia