Clinical trial · Interventional
Switch-Maintenance Gemcitabine After First-Line Chemotherapy In Patients With Malignant Pleural Mesothelioma
Switch-Maintenance Gemcitabine After First-Line Chemotherapy (Pemetrexed-Platinum) In Patients With Malignant Pleural Mesothelioma In Ain Shams University Hospitals
NCT05660616CI-TRIAL-00080225completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
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
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 |
|---|---|---|---|
| Malignant Pleural Mesothelioma | Pleural Malignant Mesothelioma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| supportive care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Gemcitabine + supportive care
- description
- Administration of maintenance gemcitabine (1000 mg/m²) on days 1 and day 8, in cycles of 21 days plus supportive care.
- interventionNames
- Drug: Gemcitabine
- Other: supportive care
- type
- OTHER
- label
- supportive care
- description
- best supportive care alone.
- interventionNames
- Other: supportive care
Primary outcomes (1)
- measure
- progression free survival
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDKaram AS, Abdelwahab S, Ezz El Din MMA, Alorabi MO. A randomized comparative study on maintenance gemcitabine versus supportive care in pleural mesothelioma. Future Oncol. 2025 Jul;21(17):2203-2213. doi: 10.1080/14796694.2025.2516412. Epub 2025 Jun 12. PMID 40501447