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Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) (PIPAC_01)

U

University of Leipzig

Status

Unknown

Conditions

Peritoneal Carcinomatosis

Treatments

Procedure: PIPAC

Study type

Observational

Funder types

Other

Identifiers

NCT03100708
PIPAC_01

Details and patient eligibility

About

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).

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

500 participants in 1 patient group

Patient with peritoneal carcinomatosis
Description:
Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed.
Treatment:
Procedure: PIPAC

Trial contacts and locations

1

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Central trial contact

Boris Jansen-Winkeln, Dr.; Ines Gockel, Prof. Dr.

Data sourced from clinicaltrials.gov

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