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

NCT05660616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-08-27

No results posted yet for this study

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)

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Abanoub Samir · Assistant Lecturer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05660616 on ClinicalTrials.gov