Switch-Maintenance Gemcitabine After First-Line Chemotherapy In Patients With Malignant Pleural Mesothelioma

Phase 2

Completed

• Conditions: Malignant Pleural Mesothelioma

• Registration Number: NCT05660616
• Lead Sponsor: Ain Shams University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Inclusion Criteria:<br><br> - Being at least 18 years old<br><br> - Histologically or cytologically confirmed unresectable malignant pleural<br> mesothelioma<br><br> - ECOG Performance status 0-2<br><br> - Completed at least four cycles of first line platinum (cisplatin or carboplatin) and<br> pemetrexed combination chemotherapy before study entry<br><br> - No evidence of disease progression following first-line treatment based on<br> radiological criteria.<br><br> - Adequate organ function is mandatory, defined as haemoglobin of at least 8.5 mg/dl,<br> platelets of at least 100×10? per L, and neutrophils of at least 1×10?/L.<br><br>Exclusion Criteria:<br><br> - Progression of disease after first line<br><br> - Pregnant females<br><br> - ECOG Performance 3-4<br><br> - Patients with sarcomatoid mesothelioma<br><br> - Patients who are candidates for curative surgery

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
progression free survival

Secondary Outcome Measures

Name	Time	Method
overall survival;Toxicity of chemotherapy