CompletedPhase 2

Gemcitabine as Maintenance Treatment for Diffuse Pleural Mesothelioma

Egypt64 participantsStarted 2020-03-15

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-Free Survival (PFS)

Timeframe: From randomization until disease progression or death from any cause, up to 36 months

Trial details

NCT IDNCT07411144

SponsorNational Cancer Institute, Egypt

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-03-15

View on ClinicalTrials.gov More Diffuse Pleural Mesothelioma (DPM) trials