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

PHASE2CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 1, 2023

Primary Completion Date

April 1, 2024

Study Completion Date

April 1, 2024

Conditions
Malignant Pleural Mesothelioma
Interventions
DRUG

Gemcitabine

"The study includes patients with unresectable malignant pleural mesothelioma who received at least 4 cycles of first line platinum (Cisplatin or Carboplatin) and pemetrexed combination chemotherapy~* Response after first line treatment will be assessed by the modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 for pleural mesothelioma.~* Patients will be randomized according to a (1:1) ratio to either Arm 1: Administration of maintenance gemcitabine (1000 mg/m²) on days 1 and day 8, in cycles of 21 days plus supportive care Arm 2 (control arm): best supportive care alone.~* Cases will be evaluated every cycle clinically and every three cycles radiologically with CTs."

OTHER

supportive care

supportive care

Trial Locations (1)

Unknown

Ain Shams University Hospital, Cairo

All Listed Sponsors
lead

Ain Shams University

OTHER