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

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

Tracking Information

• First Submitted Date: November 15, 2016
• First Posted Date: April 4, 2017
• Last Update Posted Date: September 25, 2019
• Study Start Date: April 2016
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: March 28, 2017): Overall Survival (years) [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 28, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Register Study of Patients With Peritoneal Carcinomatosis Treated With PIPAC (Pressurized Intra-peritoneal Aerosol-Chemotherapy)
• 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.
• 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).
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients suffer from peritoneal carcinomatosis.
• Condition: Peritoneal Carcinomatosis

Intervention

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

Study Groups/Cohorts

Patient with peritoneal carcinomatosis

Patient with peritoneal carcinomatosis and the Indication for local therapy. The Clinics tumor-board advice is needed.

Intervention: Procedure: PIPAC

Publications *

• Gockel I, Jansen-Winkeln B, Haase L, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized IntraPeritoneal Aerosol Chemotherapy (PIPAC) in patients with peritoneal metastasized colorectal, appendiceal and small bowel cancer. Tumori. 2020 Feb;106(1):70-78. doi: 10.1177/0300891619868013. Epub 2019 Aug 30.
• Gockel I, Jansen-Winkeln B, Haase L, Rhode P, Mehdorn M, Niebisch S, Moulla Y, Lyros O, Lordick F, Schierle K, Wittekind C, Thieme R. Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in Gastric Cancer Patients with Peritoneal Metastasis (PM): Results of a Single-Center Experience and Register Study. J Gastric Cancer. 2018 Dec;18(4):379-391. doi: 10.5230/jgc.2018.18.e37. Epub 2018 Dec 14.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: March 28, 2017): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 2021
• Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT03100708
• Other Study ID Numbers: PIPAC_01
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Dr. Boris Jansen-Winkeln, University of Leipzig
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Leipzig
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ines Gockel, Prof. Dr.; Universitätsklinikum Leipzig

• PRS Account: University of Leipzig
• Verification Date: September 2019