peritoneal cancer
Conditions
Interventions
The laparoscopic HIPEC procedure: open introduction of a 10 mm trocar at the
umbilicus, CO2 pneumoperitoneum, three additional trocars of 10 mm, complete
dissection of adhesions, peritonectomy or ot
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients diagnosed with adenocarcinoma of the colon and proximal rectum and at least one of the following risk factors for PC will be considered for inclusion: * pT4 * (Resected) local peritoneal nodules in the close proximity of the primary tumour * Primary tumour presenting with obstruction and/or perforation * Positivie cytology in peritoneal lavage * Ovarian metastasis or omental metastasis;Eligibility criteria are: * age between 18 and 75 years, * ECOG performance status 0 to 2, * written informed consent obtained prior to any study specific screening procedures, * white blood cell count at least 3000/mm3, platelet count at least 100.000/mm3, * no bleeding diathesis or coagulopathy, * creatinine normal or creatinine clearance at least 50 ml/min
Exclusion criteria
Exclusion criteria: * liver and/or lung metastases, * pregnant or lactating women, * unstable or uncompensated respiratory or cardiac disease, * serious active infections, * other concurrent chemotherapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is hospital stay. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints are treatment related morbidity defined as surgical complications and toxicity related to the intraperitoneal chemotherapy. | — |
Countries
Netherlands
Outcome results
None listed