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

NCT05660616 | Completed Phase 2

• 1 other identifier: SMGFM
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mesothelioma; Switch-maintenance; Gemcitabine

Outcome Measures

Primary Outcomes (1)

• progression free survival

  It is the time from randomization to disease progression or death from any cause

  2 years

Secondary Outcomes (2)

• overall survival

  2 years

• Toxicity of chemotherapy

  2 years

Study Arms (2)

Gemcitabine + supportive care

EXPERIMENTAL

Administration of maintenance gemcitabine (1000 mg/m²) on days 1 and day 8, in cycles of 21 days plus supportive care.

Drug: Gemcitabine; Other: supportive care

supportive care

OTHER

best supportive care alone.

Other: supportive care

Interventions

Gemcitabine DRUG

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.

Also known as: Gemzar

Gemcitabine + supportive care

supportive care OTHER

supportive care

Gemcitabine + supportive care; supportive care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Progression of disease after first line
• Pregnant females
• ECOG Performance 3-4
• Patients with sarcomatoid mesothelioma
• Patients who are candidates for curative surgery

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospital

Cairo, Egypt

Location

Related Publications (1)

• Karam 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 DERIVED

MeSH Terms

Conditions

Mesothelioma, Malignant; Mesothelioma

Interventions

Gemcitabine; Palliative Care

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Abanoub Samir

  Assistant Lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 21, 2022
• Study Start: April 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)