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

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Mesothelioma is an aggressive form of cancer. Treatments are available, but for many people, a cure isn't possible.

This thesis is to assess the efficacy and safety of switch-maintenance Gemcitabine in Mesothelioma patients after first line chemotherapy (Pemetrexed-Platinum)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ain Shams University
• Treatments: Gemcitabine

Criteria

Inclusion Criteria:

• Being at least 18 years old

• Histologically or cytologically confirmed unresectable malignant pleural mesothelioma

• ECOG Performance status 0-2

• Completed at least four cycles of first line platinum (cisplatin or carboplatin) and pemetrexed combination chemotherapy before study entry

• No evidence of disease progression following first-line treatment based on radiological criteria.

• Adequate organ function is mandatory, defined as haemoglobin of at least 8.5 mg/dl, platelets of at least 100×10⁹ per L, and neutrophils of at least 1×10⁹/L.

Exclusion Criteria:

• Progression of disease after first line

• Pregnant females

• ECOG Performance 3-4

• Patients with sarcomatoid mesothelioma

• Patients who are candidates for curative surgery