Peritoneal MesotheliomaPhase 2MESOTIPNCT03875144
Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)
A Phase 2 study testing PIPAC, Cisplatin and Pemetrexed in people with Peritoneal Mesothelioma and Peritoneal Carcinomatosis, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
MESOTIP is a randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma In this study, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Mesothelioma, Peritoneal Carcinomatosis
- What is being tested?
- PIPAC, Cisplatin and Pemetrexed
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 10 Sep 2020to Jun 2027
- 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
- PS (or WHO) <2
- Histologically-confirmed diagnosis of peritoneal malignant mesothelioma
- No previous line of treatment (both medical and surgical oncologic treatments) for this disease
- Peritoneal Carcinomatosis Index (PCI)>27 or at least 4 on the small bowel with serosal involvement contraindicating the cytoreductive surgery because of the impossibility to preserve a length >=1.5 m of uninvolved small bowel
- Written and dated informed consent
- Affiliated to the French national social security system
Who cannot join
- WHO performance status ≥ 2
- Any contraindication to chemotherapy and/or radiotherapy
- Any contraindication to repeated laparoscopy
- Symptomatic cardiac or coronary insufficiency
- Severe renal insufficiency
- Progressive active infection or any other severe medical condition
Show all 12Show fewer
- Intestinal occlusion non responsive to medical treatment
- Other cancer treated within the last 2 years except in situ cervical carcinoma or basocellular/spinocellular carcinoma
- Pregnant or breast-feeding woman
- Previously operated patients where laparoscopy is not feasible
- Persons deprived of liberty or under guardianship or incapable of giving consent
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Multicenter Randomized Trial Evaluating the Association of PIPAC and Systemic Chemotherapy Versus Systemic Chemotherapy Alone as 1st-line Treatment of Malignant Peritoneal Mesothelioma
MESOTIP is a randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma In this study, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of standard intravenous chemotherapy (Cisplatine+Pemetrexed).
MESOTIP aim to show an improvement of the overall survival in the experimental arm.
Read the detailed description
Malignant peritoneal mesothelioma (MPM) is a rare tumoral disease characterized by the diffuse involvement of the peritoneal serosa. The incidence of all mesotheliomas is estimated quite differently in various reports with the highest rates in industrialized countries. In France, the estimated incidence is 300 cases/year. Three types of malignant mesotheliomas are described in the WHO classification: epithelioid, sarcomatoid and biphasic.
The standard treatment of MPM is surgery. It has been shown that cytoreductive surgery (CRS) associated to hyperthermic intraperitoneal chemotherapy (HIPEC) improves prognosis resulting in a median overall survival of 29.5 months to 53 months and an 5 years overall survival rate ranging between 39 to 63%. Cytoreductive surgery should be complete or almost complete (CCR0/1) as macroscopic residual disease deteriorates prognosis.
However some patients are not eligible for surgery due to the locoregional extension of the disease. Although debulking surgery may still be considered, its results are less encouraging than CRS and HIPEC.
The neoadjuvant treatment combining Cisplatin and Pemetrexed became a routinely applied option for initially unresectable patients after the publication of an open-label study inspired by previous results of a randomized trial in pleural mesothelioma. This study showed a benefit in median survival of 5 months and an increase in the response rate of 10%. Ever since, other phase II studies were proposed but their benefit is still limited. Pleural mesothelioma which is more common and represents the model of choice for the treatment of peritoneal mesothelioma has also benefitted from phase III studies analyzing the addition of a targeted therapy (Bevacizumab) and phase II trials proposing immunotherapy.
By contrast, peritoneal mesothelioma was the setting of choice for testing intraperitoneal administration of chemotherapy either as early postoperative intraperitoneal chemotherapy (EPIC) or as neoadjuvant intraperitoneal chemotherapy. Both studies offered promising results showing a sensitivity of MPM to intraperitoneal administration.
Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) has recently been developed and shows interesting results in the neoadjuvant context of several peritoneal carcinomatoses while producing little toxicity. PIPAC is a modality of repeated administration of intraperitoneal chemotherapy during laparoscopy using aerosols at the pressure of the capnoperitoneum (12mmHg). Data from ex-vivo, in-vivo and human studies demonstrated a higher local drug bioavailability when compared to liquid IP chemotherapy. PIPAC was tested in the setting of malignant mesothelioma showing encouraging results.
In our study MESOTIP, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of standard intravenous chemotherapy (Cisplatine+Pemetrexed).
Although retrospective reports showing the interest of PIPAC in the neoadjuvant setting for different peritoneal carcinomatosis origins were published, MESOTIP would be the first study to combine PIPAC to systemic chemotherapy in the first-line of treatment and to only include patients not eligible for surgical treatment and proposing a complete cytoreductive surgery associated to HIPEC for patients converted to resectability.
MESOTIP aim to show an improvement of the overall survival in the experimental arm.
- Conditions
- Peritoneal Mesothelioma, Peritoneal Carcinomatosis
- Being tested
- PIPAC, Cisplatin, Pemetrexed
- Keywords
- Peritoneal mesothelioma, PIPAC, Surgical oncology, Peritoneal Carcinomatosis
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPACProcedure or surgery
Also called Cisplatin, Doxorubicin
Pressurized IntraPeritoneal Aerosol Chemotherapy of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks
CisplatinDrug
standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)
PemetrexedDrug
standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)
| Study group | Role | What they receive |
|---|---|---|
| association of PIPAC and systemic chemotherapy | Experimental | 4 PIPAC of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks alternating with standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²) Receives: Procedure: PIPAC; Drug: Cisplatin; Drug: Pemetrexed |
| systemic chemotherapy alone | Active comparator | 6 cycles of Cisplatin 75mg/m² + Pemetrexed 500mg/m² Receives: Drug: Cisplatin; Drug: Pemetrexed |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
The overall survival is defined as the time from the date of randomization to the date of death from any cause
Measured: from randomization of first patient until the database cut-off
Secondary outcomes (5)
Response to treatment using PFS
Progression free survival (PFS) defined as the time from the date of randomization to the date of any progression or death. PFS will be described with median PFS, 1 and 2y-PFS rate
Measured: week 10, week21,every 4 months during 2 years
Adverse event
Safety according to CTCAE v5.0. Complications related to PIPAC will also be defined according to CTCAE v5.0 as recent publications in the field of peritoneal carcinomatosis suggest that this classification is more reliable when compared with the Clavien Dindo classification for the peritoneal carcinomatosis surgery
Measured: during treatment
Feasibility of compliance
Feasibility rate of compliance defined as the percentage of patients who received 6 cycles of systemic chemotherapy and 4 PIPAC (for experimental arm).
Measured: Week 21
Conversion to resectability
Conversion to resectability rate defined as the percentage of patients eligible for cytoreductive surgery and HIPEC at the end of the treatment out of the total number of patients. Patients are eligible for surgery if preservation of at least 1.5 m of small bowel and of at least 2 m of lower gastrointestinal tube is feasible in case of complete cytoreduction.
Measured: surgery
Quality of life evaluation
Quality of life EORTC QLQ-C30 questionnaires according to EORTC Guidelines
Measured: baseline, week10, week21, FU every 4 months during 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2019
- Study start10 Sep 2020
- Primary completion16 Dec 2024
- Study completionJun 2027 (estimated)
Why it stopped: This decision was taken following the occurrence of three cases of serious and unexpected suspected adverse reactions (SUSARs), specifically febrile neutropenia, in participants assigned to the experimental arm combining PIPAC with systemic chemothe
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Peritoneal MesotheliomaStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivia SGARBURA, MD, Principal investigator, Institut régional du Cancer de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03875144
- Sponsor's protocol ID
- PROICM 2019-03 MES
- Acronym
- MESOTIP
- Status last verified
- Feb 2026
- First submitted
- 4 Mar 2019
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim J, Bhagwandin S, Labow DM. Malignant peritoneal mesothelioma: a review. Ann Transl Med. 2017 Jun;5(11):236. doi: 10.21037/atm.2017.03.96.
PubMed 28706904Boffetta P. Epidemiology of peritoneal mesothelioma: a review. Ann Oncol. 2007 Jun;18(6):985-90. doi: 10.1093/annonc/mdl345. Epub 2006 Oct 9.
PubMed 17030547Bossard N, Velten M, Remontet L, Belot A, Maarouf N, Bouvier AM, Guizard AV, Tretarre B, Launoy G, Colonna M, Danzon A, Molinie F, Troussard X, Bourdon-Raverdy N, Carli PM, Jaffre A, Bessaguet C, Sauleau E, Schvartz C, Arveux P, Maynadie M, Grosclaude P, Esteve J, Faivre J. Survival of cancer patients in France: a population-based study from The Association of the French Cancer Registries (FRANCIM). Eur J Cancer. 2007 Jan;43(1):149-60. doi: 10.1016/j.ejca.2006.07.021. Epub 2006 Nov 3.
PubMed 17084622Alexander HR Jr, Li CY, Kennedy TJ. Current Management and Future Opportunities for Peritoneal Metastases: Peritoneal Mesothelioma. Ann Surg Oncol. 2018 Aug;25(8):2159-2164. doi: 10.1245/s10434-018-6337-5. Epub 2018 Feb 8.
PubMed 29423664Yan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F, Moran BJ, Morris DL, Chua TC, Piso P, Sugarbaker PH. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol. 2009 Dec 20;27(36):6237-42. doi: 10.1200/JCO.2009.23.9640. Epub 2009 Nov 16.
PubMed 19917862Baratti D, Kusamura S, Cabras AD, Bertulli R, Hutanu I, Deraco M. Diffuse malignant peritoneal mesothelioma: long-term survival with complete cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC). Eur J Cancer. 2013 Oct;49(15):3140-8. doi: 10.1016/j.ejca.2013.05.027. Epub 2013 Jul 4.
PubMed 23831335Helm JH, Miura JT, Glenn JA, Marcus RK, Larrieux G, Jayakrishnan TT, Donahue AE, Gamblin TC, Turaga KK, Johnston FM. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. 2015 May;22(5):1686-93. doi: 10.1245/s10434-014-3978-x. Epub 2014 Aug 15.
PubMed 25124472
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter Randomized Trial Evaluating the Association of PIPAC and Systemic Chemotherapy Versus Systemic Chemotherapy Alone as 1st-line Treatment of Malignant Peritoneal Mesothelioma
- ClinicalTrials.gov ID
- NCT03875144
- Acronym / sponsor ID
- MESOTIP / PROICM 2019-03 MES
- Conditions
- Peritoneal Mesothelioma, Peritoneal Carcinomatosis
- Keywords
- Peritoneal mesothelioma, PIPAC, Surgical oncology, Peritoneal Carcinomatosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: This decision was taken following the occurrence of three cases of serious and unexpected suspected adverse reactions (SUSARs), specifically febrile neutropenia, in participants assigned to the experimental arm combining PIPAC with systemic chemothe
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 14 Mar 2019 (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.
MESOTIP is a randomized trial evaluating the association of PIPAC and systemic chemotherapy versus systemic chemotherapy alone as 1st-line treatment of Malignant Peritoneal Mesothelioma In this study, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of standard intravenous chemotherapy (Cisplatine+Pemetrexed).
MESOTIP aim to show an improvement of the overall survival in the experimental arm.
Detailed description
Malignant peritoneal mesothelioma (MPM) is a rare tumoral disease characterized by the diffuse involvement of the peritoneal serosa. The incidence of all mesotheliomas is estimated quite differently in various reports with the highest rates in industrialized countries. In France, the estimated incidence is 300 cases/year. Three types of malignant mesotheliomas are described in the WHO classification: epithelioid, sarcomatoid and biphasic.
The standard treatment of MPM is surgery. It has been shown that cytoreductive surgery (CRS) associated to hyperthermic intraperitoneal chemotherapy (HIPEC) improves prognosis resulting in a median overall survival of 29.5 months to 53 months and an 5 years overall survival rate ranging between 39 to 63%. Cytoreductive surgery should be complete or almost complete (CCR0/1) as macroscopic residual disease deteriorates prognosis.
However some patients are not eligible for surgery due to the locoregional extension of the disease. Although debulking surgery may still be considered, its results are less encouraging than CRS and HIPEC.
The neoadjuvant treatment combining Cisplatin and Pemetrexed became a routinely applied option for initially unresectable patients after the publication of an open-label study inspired by previous results of a randomized trial in pleural mesothelioma. This study showed a benefit in median survival of 5 months and an increase in the response rate of 10%. Ever since, other phase II studies were proposed but their benefit is still limited. Pleural mesothelioma which is more common and represents the model of choice for the treatment of peritoneal mesothelioma has also benefitted from phase III studies analyzing the addition of a targeted therapy (Bevacizumab) and phase II trials proposing immunotherapy.
By contrast, peritoneal mesothelioma was the setting of choice for testing intraperitoneal administration of chemotherapy either as early postoperative intraperitoneal chemotherapy (EPIC) or as neoadjuvant intraperitoneal chemotherapy. Both studies offered promising results showing a sensitivity of MPM to intraperitoneal administration.
Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) has recently been developed and shows interesting results in the neoadjuvant context of several peritoneal carcinomatoses while producing little toxicity. PIPAC is a modality of repeated administration of intraperitoneal chemotherapy during laparoscopy using aerosols at the pressure of the capnoperitoneum (12mmHg). Data from ex-vivo, in-vivo and human studies demonstrated a higher local drug bioavailability when compared to liquid IP chemotherapy. PIPAC was tested in the setting of malignant mesothelioma showing encouraging results.
In our study MESOTIP, patients in the experimental arm will be treated by 4 PIPAC (Cisplatine+Doxorubicine) alternating with 6 cycles of standard intravenous chemotherapy (Cisplatine+Pemetrexed).
Although retrospective reports showing the interest of PIPAC in the neoadjuvant setting for different peritoneal carcinomatosis origins were published, MESOTIP would be the first study to combine PIPAC to systemic chemotherapy in the first-line of treatment and to only include patients not eligible for surgical treatment and proposing a complete cytoreductive surgery associated to HIPEC for patients converted to resectability.
MESOTIP aim to show an improvement of the overall survival in the experimental arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| association of PIPAC and systemic chemotherapy | Experimental | Procedure: PIPAC, Drug: Cisplatin, Drug: Pemetrexed4 PIPAC of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks alternating with standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²) |
| systemic chemotherapy alone | Active comparator | Drug: Cisplatin, Drug: Pemetrexed6 cycles of Cisplatin 75mg/m² + Pemetrexed 500mg/m² |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- PS (or WHO) <2
- Histologically-confirmed diagnosis of peritoneal malignant mesothelioma
- No previous line of treatment (both medical and surgical oncologic treatments) for this disease
- Peritoneal Carcinomatosis Index (PCI)>27 or at least 4 on the small bowel with serosal involvement contraindicating the cytoreductive surgery because of the impossibility to preserve a length >=1.5 m of uninvolved small bowel
Key exclusion criteria (12 listed)
- WHO performance status ≥ 2
- Any contraindication to chemotherapy and/or radiotherapy
- Any contraindication to repeated laparoscopy
- Symptomatic cardiac or coronary insufficiency
- Severe renal insufficiency
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 |
|---|---|---|
| PIPACAlso: Cisplatin, DoxorubicinPressurized IntraPeritoneal Aerosol Chemotherapy of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks | Procedure or surgery | association of PIPAC and systemic chemotherapy |
| Cisplatinstandard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²) | Drug | association of PIPAC and systemic chemotherapy, systemic chemotherapy alone |
| Pemetrexedstandard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²) | Drug | association of PIPAC and systemic chemotherapy, systemic chemotherapy alone |
Primary outcome
overall survival
Time frame: from randomization of first patient until the database cut-off
The overall survival is defined as the time from the date of randomization to the date of death from any cause
5 secondary outcomes
Response to treatment using PFS
Time frame: week 10, week21,every 4 months during 2 years
Adverse event
Time frame: during treatment
Feasibility of compliance
Time frame: Week 21
Conversion to resectability
Time frame: surgery
Quality of life evaluation
Time frame: baseline, week10, week21, FU every 4 months during 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Background: PubMed 28706904Kim J, Bhagwandin S, Labow DM. Malignant peritoneal mesothelioma: a review. Ann Transl Med. 2017 Jun;5(11):236. doi: 10.21037/atm.2017.03.96.
- Background: PubMed 17030547Boffetta P. Epidemiology of peritoneal mesothelioma: a review. Ann Oncol. 2007 Jun;18(6):985-90. doi: 10.1093/annonc/mdl345. Epub 2006 Oct 9.
- Background: PubMed 17084622Bossard N, Velten M, Remontet L, Belot A, Maarouf N, Bouvier AM, Guizard AV, Tretarre B, Launoy G, Colonna M, Danzon A, Molinie F, Troussard X, Bourdon-Raverdy N, Carli PM, Jaffre A, Bessaguet C, Sauleau E, Schvartz C, Arveux P, Maynadie M, Grosclaude P, Esteve J, Faivre J. Survival of cancer patients in France: a population-based study from The Association of the French Cancer Registries (FRANCIM). Eur J Cancer. 2007 Jan;43(1):149-60. doi: 10.1016/j.ejca.2006.07.021. Epub 2006 Nov 3.
- Background: PubMed 29423664Alexander HR Jr, Li CY, Kennedy TJ. Current Management and Future Opportunities for Peritoneal Metastases: Peritoneal Mesothelioma. Ann Surg Oncol. 2018 Aug;25(8):2159-2164. doi: 10.1245/s10434-018-6337-5. Epub 2018 Feb 8.
- Background: PubMed 19917862Yan TD, Deraco M, Baratti D, Kusamura S, Elias D, Glehen O, Gilly FN, Levine EA, Shen P, Mohamed F, Moran BJ, Morris DL, Chua TC, Piso P, Sugarbaker PH. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: multi-institutional experience. J Clin Oncol. 2009 Dec 20;27(36):6237-42. doi: 10.1200/JCO.2009.23.9640. Epub 2009 Nov 16.
- Background: PubMed 23831335Baratti D, Kusamura S, Cabras AD, Bertulli R, Hutanu I, Deraco M. Diffuse malignant peritoneal mesothelioma: long-term survival with complete cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy (HIPEC). Eur J Cancer. 2013 Oct;49(15):3140-8. doi: 10.1016/j.ejca.2013.05.027. Epub 2013 Jul 4.
- Background: PubMed 25124472Helm JH, Miura JT, Glenn JA, Marcus RK, Larrieux G, Jayakrishnan TT, Donahue AE, Gamblin TC, Turaga KK, Johnston FM. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy for malignant peritoneal mesothelioma: a systematic review and meta-analysis. Ann Surg Oncol. 2015 May;22(5):1686-93. doi: 10.1245/s10434-014-3978-x. Epub 2014 Aug 15.
- 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.
Olivia SGARBURA, MD principal investigator
Institut régional du Cancer de Montpellier
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 PIPAC, Cisplatin and Pemetrexed in people with Peritoneal Mesothelioma and Peritoneal Carcinomatosis, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
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 7 inclusion and 12 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: paused, as of the sponsor's last update on 9 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 France. 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?
Results are not available in the source record.
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?
overall survival (time frame: from randomization of first patient until the database cut-off). 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 NCT03875144, which also lists 7 linked publications.
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 9 Feb 2026.