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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

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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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