PIPAC-OPC2: Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy -
Study Details
Study Description
Brief Summary
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 or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
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Outcome Measures
Primary Outcome Measures
- Number of patients with major/complete histologic response (PRGS 1+2) peritoneal biopsies, within a series of three PIPAC procedures. [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) [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 [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Histological or cytological verified gastrointestinal-, ovarian- or primary peritoneal malignancy (based on tissue from the primary tumor and/or its metastases).
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Ovarian cancer patients must be platinum resistant and have completed at least one line of chemotherapy for platinum resistant disease.
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Radiological, histological or cytological evidence of PC.
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No indication for CRS and HIPEC (according to National Guidelines).
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Performance status 0-1.
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No more than a single extra-peritoneal metastasis.
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Age > 18 years.
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Females must be post-menopausal
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Written informed consent must be obtained according to the local Ethics Committee requirements.
Exclusion Criteria:
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Symptomatic small bowel obstruction (i.e. total parenteral nutrition, nasogastric tube).
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Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
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A history of allergic reaction to platinum containing compounds or doxorubicin.
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Renal impairment, defined as GFR < 40 ml/min, (Cockcroft-Gault Equation).
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Myocardial insufficiency, defined as NYHA class > 2.
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Impaired liver function defined as bilirubin ≥ 1.5 x UNL (upper normal limit).
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Inadequate hematological function defined as ANC ≤ 1.5 x 109/l and platelets ≤ 100 x109/l.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Surgery, Odense University Hospital | Odense | Denmark | 5000 |
Sponsors and Collaborators
- Michael Bau Mortensen
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Solass W, Giger-Pabst U, Zieren J, Reymond MA. Pressurized intraperitoneal aerosol chemotherapy (PIPAC): occupational health and safety aspects. Ann Surg Oncol. 2013 Oct;20(11):3504-11. doi: 10.1245/s10434-013-3039-x. Epub 2013 Jun 14.
- Solass W, Kerb R, Mürdter T, Giger-Pabst U, Strumberg D, Tempfer C, Zieren J, Schwab M, Reymond MA. Intraperitoneal chemotherapy of peritoneal carcinomatosis using pressurized aerosol as an alternative to liquid solution: first evidence for efficacy. Ann Surg Oncol. 2014 Feb;21(2):553-9. doi: 10.1245/s10434-013-3213-1. Epub 2013 Sep 5.
- Tempfer CB, Celik I, Solass W, Buerkle B, Pabst UG, Zieren J, Strumberg D, Reymond MA. Activity of Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin and doxorubicin in women with recurrent, platinum-resistant ovarian cancer: preliminary clinical experience. Gynecol Oncol. 2014 Feb;132(2):307-11. doi: 10.1016/j.ygyno.2013.11.022. Epub 2013 Nov 23.
- PIPAC-OPC2