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Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)

NCT03100708 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2019-09-25

No results posted yet for this study

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).

Conditions

  • Peritoneal Carcinomatosis

Interventions

PROCEDURE

PIPAC

* 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 & Collaborators

  • University of Leipzig

    lead OTHER

Principal Investigators

  • Ines Gockel, Prof. Dr. · Universitätsklinikum Leipzig

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03100708 on ClinicalTrials.gov