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Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy - (PIPAC-OPC2)

This study is currently recruiting participants.
Verified September 2017 by Michael Bau Mortensen, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03287375
First Posted: September 19, 2017
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael Bau Mortensen, Odense University Hospital
  Purpose
This is a study, where the efficacy of Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) against peritoneal metastases will be evaluated. Furthermore, this study will focus on the best evaluation method, where both Quality of Life questionnaires, repeated histology, cytology and MRI will be used.

Condition Intervention Phase
Peritoneum; Carcinomatosis Peritoneal Neoplasms Peritoneal Metastases Chemotherapy Effect Chemotherapeutic Toxicity Quality of Life Histologic Progression Drug: PIPAC Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Cohorte study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol - The PIPAC-OPC2 Trial

Further study details as provided by Michael Bau Mortensen, Odense University Hospital:

Primary Outcome Measures:
  • Number of patients with major/complete histologic response (PRGS 1+2) peritoneal biopsies, within a series of three PIPAC procedures. [ Time Frame: 4 years ]
    Objective Tumor response will be evaluated by the Peritoneal Regression Grading Score based on repeated peritoneal biopsies during each PIPAC procedure.


Secondary Outcome Measures:
  • Number of patients with improved Quality of Life (QoL) [ Time Frame: 4 years ]
    Based on EORTC QLQC30 questionnaire at baseline and after 3 PIPAC treatments

  • Number of patients where MRI is accurate in describing PM distribution and progressive/regressive disease [ Time Frame: 4 years ]
    Based on MRI of the abdomen at baseline and after 3 PIPAC treatments, it will be evaluated, whether MRI can detect PM and whether MRI can be used to evaluate progression/regression during PIPAC treatment. Comparative gold standard is laparoscopy including biopsies


Estimated Enrollment: 137
Actual Study Start Date: December 1, 2016
Estimated Study Completion Date: December 1, 2020
Estimated Primary Completion Date: December 1, 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PIPAC
Peritoneal metastases (PM) from colorectal or appendiceal cancer will be treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) using oxaliplatin 92 mg/m2 in 150 ml dextrose. Peritoneal metastases (PM) from other GI or gynecologic cancers will be treated with Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) using cisplatin 7.5 mg/m2 in 150 ml saline combined with doxorubicin 1.5 mg/m2 in 50 ml saline. PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg and the aerosolised chemotherapy will be nebulized at a maximum pressure of 200 PSI and a flow rate of 0.5 ml/min. There is no upper number of allowed PIPAC treatments, but they will be planned in series of 3 with 5 weeks interval.
Drug: PIPAC
Other Names:
  • Cisplatin
  • Doxorubicin
  • Oxaliplatin

Detailed Description:

Patients with peritoneal metastases (PM) will be reviewed by the interdisciplinary tumor board and included based on predefined in- and exclusion criteria. Eligible candidates with primary colorectal or appendiceal cancers will be treated with intraperitoneal oxaliplatin delivered by the PIPAC procedure, while patients with other primary cancers will be treated with a combination of cisplatin and doxorubicin. Three PIPAC treatments will be scheduled in intervals of five weeks. MRI and QoL questionnaires will be performed at baseline and after three PIPAC treatments. If the patients respond to the PIPAC treatment, further courses of PIPAC can be planned at the tumour board meeting.

In brief, PIPAC is performed during a standard laparoscopy using two access ports, where the magnitude of PM is evaluated using the Peritoneal Carcinosis Index and the Dutch 7 regions count. Afterwards, the peritoneum is biopsied at different regions and peritoneal lavage fluid is sent for cytology. Then, chemotherapy is aerosolised within the abdomen, and after 30 minutes, the aerosol has been absorbed by the peritoneum, and the patient is closed according to departmental guidelines. The patients are expectedly discharged within 24 hours, and will after each PIPAC treatment be screened for adverse events using the CTCAE and Dindo-Clavien classification.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histological or cytological verified gastrointestinal-, ovarian- or primary peritoneal malignancy (based on tissue from the primary tumor and/or its metastases).
  • Ovarian cancer patients must be platinum resistant and have completed at least one line of chemotherapy for platinum resistant disease.
  • Radiological, histological or cytological evidence of PC.
  • No indication for CRS and HIPEC (according to National Guidelines).
  • Performance status 0-1.
  • No more than a single extra-peritoneal metastasis.
  • Age > 18 years.
  • Females must be post-menopausal
  • Written informed consent must be obtained according to the local Ethics Committee requirements.

Exclusion Criteria:

  • Symptomatic small bowel obstruction (i.e. total parenteral nutrition, nasogastric tube).
  • Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
  • A history of allergic reaction to platinum containing compounds or doxorubicin.
  • Renal impairment, defined as GFR < 40 ml/min, (Cockcroft-Gault Equation).
  • Myocardial insufficiency, defined as NYHA class > 2.
  • Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
  • Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x109/l.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287375


Contacts
Contact: Martin Graversen, MD ouh.ode.a.pipac@rsyd.dk
Contact: Michael Mortensen, Professor ouh.ode.a.pipac@rsyd.dk

Locations
Denmark
Department of Surgery, Odense University Hospital Recruiting
Odense, Denmark, 5000
Principal Investigator: Michael B Mortensen, MD, Ph.D.         
Sponsors and Collaborators
Michael Bau Mortensen
  More Information

Publications:
Responsible Party: Michael Bau Mortensen, Professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03287375     History of Changes
Other Study ID Numbers: PIPAC-OPC2
First Submitted: September 2, 2017
First Posted: September 19, 2017
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Publications and presentations will be based on patient data, but the database is not open to other researchers.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Disease Progression
Carcinoma
Disease Attributes
Pathologic Processes
Digestive System Diseases
Peritoneal Diseases
Oxaliplatin
Cisplatin
Doxorubicin
Antineoplastic Agents
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action