Malignant Pleural MesotheliomaPhase 2NCT05660616
Switch-Maintenance Gemcitabine After First-Line Chemotherapy In Patients With Malignant Pleural Mesothelioma
A Phase 2 study testing Gemcitabine and supportive care in people with Malignant Pleural Mesothelioma, run by Ain Shams University at 1 site in Egypt.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Pleural Mesothelioma
- What is being tested?
- Gemcitabine and supportive care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Apr 2024
- 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
- 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.
Who cannot join
- Progression of disease after first line
- Pregnant females
- ECOG Performance 3-4
- Patients with sarcomatoid mesothelioma
- Patients who are candidates for curative surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Switch-Maintenance Gemcitabine After First-Line Chemotherapy (Pemetrexed-Platinum) In Patients With Malignant Pleural Mesothelioma In Ain Shams University Hospitals
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)
Read the detailed description
Malignant pleural mesothelioma is a rare but aggressive cancer of the pleural lining.
Malignant pleural mesothelioma accounted for 30,870 new cancer cases and 26,278 deaths worldwide in 2020.
In Egypt, Malignant pleural mesothelioma accounted for 337 new cases and 307 deaths in 2020.
Long-term exposure to asbestos is a well-established risk factor for Malignant pleural mesothelioma. It accounts for almost 80% of cases.
Malignant pleural mesothelioma is classified into three histologic subtypes: epithelioid, sarcomatoid, and biphasic. Epithelioid histology confers the most favorable prognosis and sarcomatoid the least.
The majority of patients with Malignant pleural mesothelioma present with breathlessness, chest pain or both. Other symptoms include fatigue, anorexia, weight loss, sweats and malaise.
Radiological imaging should be undertaken in all patients as it can provide valuable diagnostic and staging information. Further investigation of suspected Malignant pleural mesothelioma requires sampling of pleural fluid for biochemical and cytological examination. Biopsies are usually required to confirm the diagnosis and identify the histological sub-type.
Patients with Malignant pleural mesothelioma should be managed by an experienced multidisciplinary team. Treatment options include surgery, radiation therapy and chemotherapy.
Front line polychemotherapy is considered the standard of care, whereas single agent chemotherapy has shown limited efficacy with disappointing response rates.
A pivotal trial led to the establishment of Cisplatin and Pemetrexed as standard first line regimen for unresectable Malignant pleural mesothelioma.
A recent phase II trial from Cancer and Leukemia Group B showed that maintenance Pemetrexed after 4 to 6 cycles of doublet chemotherapy induction did not prolong progression free survival over placebo.
Adding Bevacizumab to first line platinum doublet resulted in an overall survival and progression free survival gain in the phase III French trial MAPS .Bevacizumab was continued as maintenance every three weeks following completion of six cycles of chemotherapy.
In a phase III trial NVALT 5 , Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy showed no benefit in time to progression.
First line Nivolumab plus Ipilimumab in phase III trial checkmate 743 provided significant and clinically meaningful improvements in overall survival versus standard of care chemotherapy.
Unfortunately, nearly all patients progress during or after first-line therapy, and no standard second line recommended treatments exist after platinum based regimen. Retreatment with pemetrexed, eventually associated with platinum compound, may be offered in patients who achieved durable disease control more than 6 months with first line chemotherapy.
Single agent chemotherapy with Vinorelbine or Gemcitabine is the preferred choice as second line treatment , mainly based on retrospective analyses or small phase II trials.
- Conditions
- Malignant Pleural Mesothelioma
- Being tested
- Gemcitabine, supportive care
- Keywords
- Mesothelioma, Switch-maintenance, Gemcitabine
- Medical subject headings
- Mesothelioma, Malignant, Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Also called Gemzar
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.
supportive careOther
supportive care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Gemcitabine; Other: supportive care |
| supportive care | Other | best supportive care alone. Receives: Other: supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression free survival
It is the time from randomization to disease progression or death from any cause
Measured: 2 years
Secondary outcomes (2)
overall survival
It is the time from randomization to death from any cause
Measured: 2 years
Toxicity of chemotherapy
toxicity of chemotherapy using CTCAE-version 5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Apr 2023
- Primary completion1 Apr 2024
- Study completion1 Apr 2024
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 Malignant Pleural MesotheliomaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abanoub Samir, Principal investigator, Assistant Lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660616
- Sponsor's protocol ID
- SMGFM
- Status last verified
- Feb 2024
- First submitted
- 5 Dec 2022
- Last updated
- 27 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40501447
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Switch-Maintenance Gemcitabine After First-Line Chemotherapy (Pemetrexed-Platinum) In Patients With Malignant Pleural Mesothelioma In Ain Shams University Hospitals
- ClinicalTrials.gov ID
- NCT05660616
- Acronym / sponsor ID
- SMGFM
- Conditions
- Malignant Pleural Mesothelioma
- Keywords
- Mesothelioma, Switch-maintenance, Gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2024 (actual)
- First posted
- 21 Dec 2022 (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.
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)
Detailed description
Malignant pleural mesothelioma is a rare but aggressive cancer of the pleural lining.
Malignant pleural mesothelioma accounted for 30,870 new cancer cases and 26,278 deaths worldwide in 2020.
In Egypt, Malignant pleural mesothelioma accounted for 337 new cases and 307 deaths in 2020.
Long-term exposure to asbestos is a well-established risk factor for Malignant pleural mesothelioma. It accounts for almost 80% of cases.
Malignant pleural mesothelioma is classified into three histologic subtypes: epithelioid, sarcomatoid, and biphasic. Epithelioid histology confers the most favorable prognosis and sarcomatoid the least.
The majority of patients with Malignant pleural mesothelioma present with breathlessness, chest pain or both. Other symptoms include fatigue, anorexia, weight loss, sweats and malaise.
Radiological imaging should be undertaken in all patients as it can provide valuable diagnostic and staging information. Further investigation of suspected Malignant pleural mesothelioma requires sampling of pleural fluid for biochemical and cytological examination. Biopsies are usually required to confirm the diagnosis and identify the histological sub-type.
Patients with Malignant pleural mesothelioma should be managed by an experienced multidisciplinary team. Treatment options include surgery, radiation therapy and chemotherapy.
Front line polychemotherapy is considered the standard of care, whereas single agent chemotherapy has shown limited efficacy with disappointing response rates.
A pivotal trial led to the establishment of Cisplatin and Pemetrexed as standard first line regimen for unresectable Malignant pleural mesothelioma.
A recent phase II trial from Cancer and Leukemia Group B showed that maintenance Pemetrexed after 4 to 6 cycles of doublet chemotherapy induction did not prolong progression free survival over placebo.
Adding Bevacizumab to first line platinum doublet resulted in an overall survival and progression free survival gain in the phase III French trial MAPS .Bevacizumab was continued as maintenance every three weeks following completion of six cycles of chemotherapy.
In a phase III trial NVALT 5 , Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy showed no benefit in time to progression.
First line Nivolumab plus Ipilimumab in phase III trial checkmate 743 provided significant and clinically meaningful improvements in overall survival versus standard of care chemotherapy.
Unfortunately, nearly all patients progress during or after first-line therapy, and no standard second line recommended treatments exist after platinum based regimen. Retreatment with pemetrexed, eventually associated with platinum compound, may be offered in patients who achieved durable disease control more than 6 months with first line chemotherapy.
Single agent chemotherapy with Vinorelbine or Gemcitabine is the preferred choice as second line treatment , mainly based on retrospective analyses or small phase II trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + supportive care | Experimental | Drug: Gemcitabine, Other: supportive careAdministration of maintenance gemcitabine (1000 mg/m²) on days 1 and day 8, in cycles of 21 days plus supportive care. |
| supportive care | Other | Other: supportive carebest supportive care alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- Progression of disease after first line
- Pregnant females
- ECOG Performance 3-4
- Patients with sarcomatoid mesothelioma
- Patients who are candidates for curative surgery
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 |
|---|---|---|
| GemcitabineAlso: GemzarThe 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. | Drug | Gemcitabine + supportive care |
| supportive caresupportive care | Other | Gemcitabine + supportive care, supportive care |
Primary outcome
progression free survival
Time frame: 2 years
It is the time from randomization to disease progression or death from any cause
2 secondary outcomes
overall survival
Time frame: 2 years
Toxicity of chemotherapy
Time frame: 2 years
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 27 Aug 2024.
- Derived from this study: PubMed 40501447Karam 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.
- Individual participant dataSharing planned: No
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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.
Abanoub Samir principal investigator
Assistant Lecturer
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 and supportive care in people with Malignant Pleural Mesothelioma, run by Ain Shams University 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 6 inclusion and 5 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 27 Aug 2024. 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 (time frame: 2 years). 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 NCT05660616, 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 27 Aug 2024.