Peritoneal Carcinomatosis
Conditions
Brief summary
The study will follow up patients with peritoneal carcinomatosis from colorectal, ovarian, gastric, pancreatic cancers and primary peritoneal tumors and undergoing a diagnostic laparoscopy / laparotomy, a PIPAC as single dose or repeated every 6 weeks. The Overall Response Rate (ORR), the Overall Survival (OS) and the Quality of Life will be assessed before every PIPAC. Biopsies of the peritoneal carcinomatosis and blood (plasma and serum) are collected with every PIPAC intervention to follow up and to document the individual success or progress of the patients. The advice of the tumor board is mandatory to confirm the indication for local chemotherapy (PIPAC).
Interventions
PROCEDUREPIPAC
* Cisplatin 7.5 mg/m2 body surface in 150 ml NaCl 0,9% + Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% in patients with ovarian, gastric, pancreatic cancer and in primary peritoneal tumors. * Oxaliplatin 92 mg/m2 body surface in 150 ml dextrose solution in patients with colorectal cancer. The chemotherapeutics will be admitted to the abdomen by a nebulizer at a pressure of 200 psi and 12 mmHG with 0.5 mL/sec. Afterwards the chemotherapeutics can react for 30min before the abdominal gas will be drained to the clinics filtering system.
Sponsors
University of Leipzig
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patient with clinical and pathological confirmed peritoneal carcinomatosis from gastric, colorectal, pancreatic, ovarian cancers or primary peritoneal tumors * Age \> 18 years * signed informed consent
Exclusion criteria
* Patient can not understand meaning and purpose of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Survival (years) | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments | 25 weeks | — |
| Overall Response Rate (CT RESIST criteria) | 5 years | Complete response |
| Quality of lfe questionnaire (EORTC QLQ-C15-PAL) | 5 years | Groenvold M et al. The development of the EORTC QLQ-C15-PAL: a shortened questionnaire for cancer patients in palliative care. European Journal of Cancer 2006; 42(1): 55-64 |
Countries
Germany
Contacts
Primary ContactInes Gockel, Prof. Dr.
Backup ContactBoris Jansen-Winkeln, Dr.
Outcome results
None listed