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Trial record 17 of 422 for:    mesothelioma

Treatment of Malignant Peritoneal Mesothelioma (MESOTIP) (MESOTIP)

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ClinicalTrials.gov Identifier: NCT03875144
Recruitment Status : Not yet recruiting
First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Institut du Cancer de Montpellier - Val d'Aurelle

Tracking Information
First Submitted Date  ICMJE March 4, 2019
First Posted Date  ICMJE March 14, 2019
Last Update Posted Date March 14, 2019
Estimated Study Start Date  ICMJE November 2019
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2019)
  • Response to treatment using PFS [ Time Frame: week 10, week21,every 4 months during 2 years ]
    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
  • Adverse event [ Time Frame: during treatment ]
    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
  • Feasibility of compliance [ Time Frame: Week 21 ]
    Feasibility rate of compliance defined as the percentage of patients who received 6 cycles of systemic chemotherapy and 4 PIPAC (for experimental arm).
  • Conversion to resectability [ Time Frame: surgery ]
    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.
  • Quality of life evaluation [ Time Frame: baseline, week10, week21, FU every 4 months during 2 years ]
    Quality of life EORTC QLQ-C30 questionnaires according to EORTC Guidelines
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Malignant Peritoneal Mesothelioma (MESOTIP)
Official Title  ICMJE 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
Brief 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peritoneal Mesothelioma
  • Peritoneal Carcinomatosis
Intervention  ICMJE
  • Procedure: PIPAC
    Pressurized IntraPeritoneal Aerosol Chemotherapy of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks
    Other Names:
    • Cisplatin
    • Doxorubicin
  • Drug: Cisplatin
    standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)
  • Drug: Pemetrexed
    standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)
Study Arms  ICMJE
  • Experimental: association of PIPAC and systemic chemotherapy
    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)
    Interventions:
    • Procedure: PIPAC
    • Drug: Cisplatin
    • Drug: Pemetrexed
  • Active Comparator: systemic chemotherapy alone
    6 cycles of Cisplatin 75mg/m² + Pemetrexed 500mg/m²
    Interventions:
    • Drug: Cisplatin
    • Drug: Pemetrexed
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 13, 2019)
66
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age ≥ 18 years
  2. PS (or WHO) <2
  3. Histologically-confirmed diagnosis of peritoneal malignant mesothelioma
  4. No previous line of treatment (both medical and surgical oncologic treatments) for this disease
  5. 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
  6. Written and dated informed consent
  7. Affiliated to the French national social security system

Exclusion Criteria:

  1. WHO performance status ≥ 2
  2. Any contraindication to chemotherapy and/or radiotherapy
  3. Any contraindication to repeated laparoscopy
  4. Symptomatic cardiac or coronary insufficiency
  5. Severe renal insufficiency
  6. Progressive active infection or any other severe medical condition
  7. Intestinal occlusion non responsive to medical treatment
  8. Other cancer treated within the last 2 years except in situ cervical carcinoma or basocellular/spinocellular carcinoma
  9. Pregnant or breast-feeding woman
  10. Previously operated patients where laparoscopy is not feasible
  11. Persons deprived of liberty or under guardianship or incapable of giving consent
  12. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Olivia SGARBURA, MD 0467614586 ext +33 Olivia.sgarbura@icm.unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03875144
Other Study ID Numbers  ICMJE PROICM 2019-03 MES
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Institut du Cancer de Montpellier - Val d'Aurelle
Study Sponsor  ICMJE Institut du Cancer de Montpellier - Val d'Aurelle
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olivia SGARBURA, MD Institut régional du Cancer de Montpellier
PRS Account Institut du Cancer de Montpellier - Val d'Aurelle
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP