Clinical Trials for Mesothelioma Patients: Pemetrexed Disodium and Cisplatin Study Criteria
Read the study criteria about a current clinical trial being conducted to study the effects of pemetrexed disodium and cisplatin for patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. At this time, the study is currently being conducted only in Zurich, Switzerland.
Study Phase, Type and Design: Phase II Interventional; Treatment, Randomized, Open Label
Official Title: Neoadjuvant Chemotherapy and Extrapleural Pneumonectomy of Malignant Pleural Mesothelioma (MPM) With or Without Hemithoracic Radiotherapy. A Randomized Multicenter Phase II Trial
Primary Outcome Measures:
• Complete macroscopic resection (part 1) [ Designated as safety issue: No ]
• Loco-regional relapse-free survival (part 2) [ Designated as safety issue: No ]
Secondary Outcome Measures:
• Response to neoadjuvant therapy (part 1) [ Designated as safety issue: No ]
• Adverse drug reaction to neoadjuvant therapy (part 1) [ Designated as safety issue: Yes ]
• Operability (part 1) [ Designated as safety issue: No ]
• Surgical complications (part 1) [ Designated as safety issue: No ]
• Reasons for non-randomization (part 1) [ Designated as safety issue: No ]
• Relapse-free or progression-free survival (part 1) [ Designated as safety issue: No ]
• Adverse reaction to postoperative radiotherapy (part 2) [ Designated as safety issue: Yes ]
• Late toxicity (part 2) [ Designated as safety issue: Yes ]
• Feasibility of postoperative radiotherapy (part 2) [ Designated as safety issue: No ]
• Relapse-free survival (part 2) [ Designated as safety issue: No ]
• Psychological distress (quality of life) (part 2) [ Designated as safety issue: No ]
• Overall survival [ Designated as safety issue: No ]
Courtesy of ClinicalTrials.gov.
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