Peritoneal carcinomatosis (PC) MedDRA version: 19.0 Level: LLT Classification code 10068069 Term: Peritoneal carcinomatosis System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Cisplatin
Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion
INN or Proposed INN: CISPLATIN
Other descriptive name: CISPLATIN
Concentration unit: gm/m2 gram(s
Sponsors
Michael Bau Mortensen
Eligibility
Sex/Gender
All
Inclusion 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. • Written informed consent must be obtained according to the local Ethics Committee requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To identify if PIPAC (Pressurized IntraPeritoneal Aerosol Chemotherapy) can induce major/complete response (PRGS 1+2), based on repeated peritoneal biopsies, within a series of three PIPAC procedures.;Secondary Objective: • To detect changes in Quality of Life (QoL) during the course of PIPAC treatment. • To assess if MRI is able to show the magnitude and distribution of PC at baseline, and if MRI can be used in the response evaluation after the third PIPAC procedure. • To create a model, that predicts who can benefit from PIPAC treatment during the first part of the study, and validate it during the last part of the study. ;Primary end point(s): Our hypothesis is, that PIPAC will induce a response in PC patients, and that this may be monitored by a change in the histological response evaluation. Based on the relatively few available data on PIPAC it seems relevant to divide the PC patients into two groups according to their primary cancer disease (“Colo-rectal” and “Other”), and to use this approach for the calculation of the number of patients needed. 1. Colo-rectal cancer patients with PC: We expect major or complete histologic response in 30% after systemic chemotherapy. After a maximum of three PIPAC series, we expect major or complete response in 50%. 2. Other cancer patients with PC: We expect major or complete histologic response in 15% after systemic chemotherapy. After a maximum of three PIPAC series, we expect major or complete response in 30%. ;Timepoint(s) of evaluation of this end point: After three PIPAC procedures, ie. 12-18 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not specified.;Timepoint(s) of evaluation of this end point: Not specified. | — |
Countries
Denmark
Contacts
Public ContactSurgical Department A
Odense University Hospital
Outcome results
None listed