Status:
COMPLETED
Treatment of Peritoneal Carcinomatosis With Pressurized IntraPeritoneal Aerosol Chemotherapy -
Lead Sponsor:
Michael Bau Mortensen
Conditions:
Peritoneum; Carcinomatosis
Peritoneal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 evaluati...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
143 Patients enrolled
Trial Details
Trial ID
NCT03287375
Start Date
December 1 2016
End Date
October 1 2022
Last Update
October 7 2022
Active Locations (1)
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1
Department of Surgery, Odense University Hospital
Odense, Denmark, 5000