Diffuse Pleural Mesothelioma (DPM)Phase 2GEMONCT07411144
Gemcitabine as Maintenance Treatment for Diffuse Pleural Mesothelioma
A Phase 2 study testing Gemcitabine (1000 mg/m2) in people with Diffuse Pleural Mesothelioma (DPM), run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Pleural Mesothelioma (DPM)
- What is being tested?
- Gemcitabine (1000 mg/m2)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Mar 2020to 15 Mar 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Adequate bone marrow function
- Adequate hepatic function
- Adequate renal function
- Ability to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
Read the 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.
- Conditions
- Diffuse Pleural Mesothelioma (DPM)
- Being tested
- Gemcitabine (1000 mg/m2)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine (1000 mg/m2)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine Maintenance Therapy | Experimental | Patients received gemcitabine as maintenance therapy in addition to best supportive care following response or stable disease after first-line platinum-based chemotherapy. Receives: Drug: Gemcitabine (1000 mg/m2) |
| Best Supportive Care | No intervention | Patients received best supportive care alone, including symptom control and palliative measures, without active anti-cancer maintenance chemotherapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From randomization until disease progression or death from any cause, up to 36 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: From randomization until death or end of follow-up, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Mar 2020
- Primary completion15 Mar 2023
- Study completion15 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diffuse Pleural Mesothelioma (DPM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. One group received gemcitabine as maintenance therapy in addition to best supportive care, while the other group received best supportive care alone. Treatment allocation remained fixed throughout the study, and no crossover between groups was permitted.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed emam salah, National Cancer Institute, Egypt
- Investigators
- Mohamed Emam Sobeih, MD, Principal investigator, National Cancer Institute,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411144
- Sponsor's protocol ID
- GEMO-MPM-2025-01
- Acronym
- GEMO
- Status last verified
- Feb 2026
- First submitted
- 1 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
Sobeih 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.
PubMed 41888696
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine as Maintenance Treatment of Diffuse Pleural Mesothelioma: Randomized Phase II Study
- ClinicalTrials.gov ID
- NCT07411144
- Acronym / sponsor ID
- GEMO / GEMO-MPM-2025-01
- Conditions
- Diffuse Pleural Mesothelioma (DPM)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 15 Mar 2023 (actual)
- Study completion
- 15 Mar 2023 (actual)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomly assigned in a 1:1 ratio to one of two parallel groups. One group received gemcitabine as maintenance therapy in addition to best supportive care, while the other group received best supportive care alone. Treatment allocation remained fixed throughout the study, and no crossover between groups was permitted.
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine Maintenance Therapy | Experimental | Drug: Gemcitabine (1000 mg/m2)Patients received gemcitabine as maintenance therapy in addition to best supportive care following response or stable disease after first-line platinum-based chemotherapy. |
| Best Supportive Care | No intervention | –Patients received best supportive care alone, including symptom control and palliative measures, without active anti-cancer maintenance chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Gemcitabine Maintenance Therapy |
Primary outcome
Progression-Free Survival (PFS)
Time frame: From randomization until disease progression or death from any cause, up to 36 months
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.
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Assessed every 8 weeks from randomization until disease progression, up to 24 months
Treatment-Related Toxicity
Time frame: From first dose of study treatment until 30 days after treatment discontinuation
Prognostic Factors Associated With Progression-Free and Overall Survival
Time frame: From randomization until death or end of follow-up, up to 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Derived from this study: PubMed 41888696Sobeih 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.
- Individual participant dataSharing planned: Undecided. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Emam Sobeih, MD principal investigator
National Cancer Institute,Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gemcitabine (1000 mg/m2) in people with Diffuse Pleural Mesothelioma (DPM), run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: From randomization until disease progression or death from any cause, up to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07411144, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.