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

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ClinicalTrials.gov Identifier: NCT03100708
Recruitment Status : Unknown
Verified September 2019 by Dr. Boris Jansen-Winkeln, University of Leipzig.
Recruitment status was:  Recruiting
First Posted : April 4, 2017
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Boris Jansen-Winkeln, University of Leipzig

Study Description
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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).

Condition or disease Intervention/treatment
Peritoneal Carcinomatosis Procedure: PIPAC

Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Molecular and Pathophysiological Mechanisms of Peritoneal Carcinomatosis and Monitoring of the Efficiency of PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy) as a Local Chemotherapeutical Treatment.
Study Start Date : April 2016
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patient with peritoneal carcinomatosis
Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed.
 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.

Other Name: Pressurized Intra-peritoneal Aerosol-Chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (years) [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments [ Time Frame: 25 weeks ]
  2. Overall Response Rate (CT RESIST criteria) [ Time Frame: 5 years ]
    Complete response

  3. Quality of lfe questionnaire (EORTC QLQ-C15-PAL) [ Time Frame: 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients suffer from peritoneal carcinomatosis.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03100708


Contacts
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Contact: Ines Gockel, Prof. Dr. +49 341 97 17200 ines.gockel@medizin.uni-leipzig.de
Contact: Boris Jansen-Winkeln, Dr. +49 341 97 17200 boris.jansen-winkeln@medizin.uni-leipzig.de

Locations
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Germany
Universitätsklinikum Leipzig - AöR Recruiting
Leipzig, Sachsen, Germany, 04103
Sponsors and Collaborators
University of Leipzig
Investigators
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Principal Investigator: Ines Gockel, Prof. Dr. Universitätsklinikum Leipzig
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Boris Jansen-Winkeln, Dr. B. Jansen-Winkeln and Prof. Dr. I. Gockel, University of Leipzig
ClinicalTrials.gov Identifier: NCT03100708    
Other Study ID Numbers: PIPAC_01
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
 Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases