Gemcitabine as Maintenance Treatment for Diffuse Pleural Mesothelioma (GEMO)

Gemcitabine as Maintenance Treatment of Diffuse Pleural Mesothelioma: Randomized Phase II Study

What is this study about?

This study looks at whether continuing chemotherapy with a drug called gemcitabine after initial treatment can help patients with diffuse pleural mesothelioma keep their cancer under control for a longer time.

Diffuse pleural mesothelioma is a rare and aggressive cancer that affects the lining of the lungs. Even after standard chemotherapy, the disease often comes back quickly. Doctors are therefore looking for maintenance treatments that may delay cancer progression.

What does this mean for patients and families?

Gemcitabine maintenance treatment may help delay cancer progression It does not clearly extend overall life expectancy Side effects are common and should be carefully discussed with the treating oncologist

Treatment decisions should consider:

Patient performance status Symptoms Personal preferences and quality of life

What does this mean for health care providers?

Gemcitabine maintenance may be an option for:

Fit patients Those who responded to first-line chemotherapy Careful patient selection is essential Monitoring for hematologic toxicity is required Further larger studies are needed to confirm survival benefit

Study Overview

• Status: Completed
• Conditions: Diffuse Pleural Mesothelioma (DPM)
• Intervention / Treatment: Drug: Gemcitabine (1000 mg/m2)

Detailed Description

Diffuse pleural mesothelioma (DPM) is an aggressive malignancy with limited therapeutic options and a high risk of early disease progression despite initial response to platinum-based chemotherapy. Although first-line systemic treatment can achieve disease control in a subset of patients, most will experience relapse within a short time interval. Strategies aimed at maintaining disease control after completion of induction chemotherapy are therefore of clinical interest.

Maintenance therapy using a non-cross-resistant cytotoxic agent represents a potential approach to delay tumor progression while preserving acceptable tolerability. Gemcitabine is an antimetabolite chemotherapeutic agent with documented activity in mesothelioma and a manageable safety profile. Its use as switch-maintenance therapy following platinum-based induction treatment may provide continued suppression of tumor growth without overlapping toxicity.

This randomized, open-label, phase II study was designed to evaluate whether gemcitabine maintenance therapy improves progression-free survival compared with best supportive care alone in patients with unresectable DPM who achieved complete response, partial response, or stable disease after first-line chemotherapy. Patients were randomized in a 1:1 ratio to receive either gemcitabine maintenance therapy plus best supportive care or best supportive care alone.

The study also explores the impact of maintenance therapy on overall survival and evaluates treatment-related toxicity. In addition, clinical and pathological factors such as performance status and histological subtype are assessed for their prognostic relevance. The results of this trial aim to inform clinical decision-making regarding post-induction management strategies in unresectable diffuse pleural mesothelioma.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Egypt
    • Cairo, Egypt, Egypt, 11765
      • National Cancer Institute, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years

Histologically confirmed unresectable diffuse pleural mesothelioma

Complete response, partial response, or stable disease after 4-6 cycles of first-line platinum-based chemotherapy, according to modified RECIST (mRECIST) criteria

Last dose of first-line chemotherapy administered within 60 days prior to randomization

Eastern Cooperative Oncology Group (ECOG) performance status 0-2

Life expectancy of at least 12 weeks

Adequate bone marrow function

Adequate hepatic function

Adequate renal function

Ability to provide written informed consent

Exclusion Criteria:

• Prior extra-pleural pneumonectomy

Evidence of active brain or leptomeningeal metastases

Weight loss >10% within 6 weeks prior to enrollment

Clinically significant ascites

Known hypersensitivity or intolerance to gemcitabine

Receipt of non-palliative radiotherapy within 3 weeks before initiation of study treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gemcitabine Maintenance Therapy; Patients received gemcitabine as maintenance therapy in addition to best supportive care following response or stable disease after first-line platinum-based chemotherapy.	Drug: Gemcitabine (1000 mg/m2); Gemcitabine was administered intravenously as maintenance therapy following response or stable disease after first-line platinum-based chemotherapy. Treatment was continued until disease progression, unacceptable toxicity, or discontinuation for clinical reasons.
No Intervention: Best Supportive Care; Patients received best supportive care alone, including symptom control and palliative measures, without active anti-cancer maintenance chemotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	Progression-free survival is defined as the time from randomization to the first documented disease progression according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) for pleural mesothelioma or death from any cause, whichever occurs first.	From randomization until disease progression or death from any cause, up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective response rate is defined as the proportion of patients achieving complete response or partial response according to modified RECIST (mRECIST) criteria for pleural mesothelioma.	Assessed every 8 weeks from randomization until disease progression, up to 24 months
Treatment-Related Toxicity	Adverse events were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	From first dose of study treatment until 30 days after treatment discontinuation
Prognostic Factors Associated With Progression-Free and Overall Survival	The association between clinical and pathological factors, including performance status at randomization and histological subtype, and progression-free and overall survival was evaluated using univariate and multivariate analyses.	From randomization until death or end of follow-up, up to 36 months

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt
• Investigators: Principal Investigator: Mohamed Emam Sobeih, MD, National Cancer Institute,Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2020
• Primary Completion (Actual): March 15, 2023
• Study Completion (Actual): March 15, 2023

Study Registration Dates

• First Submitted: February 1, 2026
• First Submitted That Met QC Criteria: February 6, 2026
• First Posted (Actual): February 13, 2026

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Gemcitabine
• Other Study ID Numbers: GEMO-MPM-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Individual participant data (IPD) will not be shared publicly. The study was conducted as a single-center academic trial, and informed consent did not include provisions for public data sharing. Additionally, data contain potentially identifiable clinical information. Aggregate results are reported in publications to ensure transparency while maintaining participant confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No