Clinical trial · Interventional
Gemcitabine as Maintenance Treatment for Diffuse Pleural Mesothelioma
Gemcitabine as Maintenance Treatment of Diffuse Pleural Mesothelioma: Randomized Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Pleural Mesothelioma (DPM) | Deep Penetrating Melanocytoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine (1000 mg/m2) | Drug | Gemcitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine Maintenance Therapy
- description
- Patients received gemcitabine as maintenance therapy in addition to best supportive care following response or stable disease after first-line platinum-based chemotherapy.
- interventionNames
- Drug: Gemcitabine (1000 mg/m2)
- type
- NO_INTERVENTION
- label
- Best Supportive Care
- description
- Patients received best supportive care alone, including symptom control and palliative measures, without active anti-cancer maintenance chemotherapy.
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
- timeFrame
- From randomization until disease progression or death from any cause, up to 36 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSobeih ME, Helal M, Yahia M, Khorshid O. Gemcitabine as maintenance treatment of diffuse pleural mesothelioma: randomized phase II study. BMC Cancer. 2026 Mar 26;26(1):458. doi: 10.1186/s12885-026-15836-3. PMID 41888696