Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy - (PIPAC-OPC2)
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|ClinicalTrials.gov Identifier: NCT03287375|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : September 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Peritoneum; Carcinomatosis Peritoneal Neoplasms Peritoneal Metastases Chemotherapy Effect Chemotherapeutic Toxicity Quality of Life Histologic Progression||Drug: PIPAC||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||137 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cohorte study|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol - The PIPAC-OPC2 Trial|
|Actual Study Start Date :||December 1, 2016|
|Estimated Primary Completion Date :||December 1, 2020|
|Estimated Study Completion Date :||December 1, 2020|
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.
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03287375
|Contact: Martin Graversen, MDfirstname.lastname@example.org|
|Contact: Michael Mortensen, Professoremail@example.com|
|Department of Surgery, Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Principal Investigator: Michael B Mortensen, MD, Ph.D.|