Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03100708
Other study ID # PIPAC_01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 2016
Est. completion date April 2021

Study information

Verified date September 2019
Source University of Leipzig
Contact Ines Gockel, Prof. Dr.
Phone +49 341 97 17200
Email ines.gockel@medizin.uni-leipzig.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date April 2021
Est. primary completion date April 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


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.

Locations

Country Name City State
Germany Universitätsklinikum Leipzig - AöR Leipzig Sachsen

Sponsors (1)

Lead Sponsor Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival (years) 5 years
Secondary The Peritoneal Carcinomatosis Index (PCI) before and after repeated PIPAC treatments 25 weeks
Secondary Overall Response Rate (CT RESIST criteria) Complete response 5 years
Secondary Quality of lfe questionnaire (EORTC QLQ-C15-PAL) 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 5 years
See also
  Status Clinical Trial Phase
Terminated NCT04826432 - Pasireotide to Reduce Clinically Relevant Digestive Leakage After Complete Cytoreductive Surgery (CRS) Plus Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) for Peritoneal Carcinomatosis Phase 2
Recruiting NCT03127774 - Surgery and Heated Intraperitoneal Chemotherapy for Adrenocortical Carcinoma Phase 2
Recruiting NCT04024917 - Impact of Cardiac Coherence on Anxiety in Patients Operated on for a Peritoneal Carcinosis N/A
Active, not recruiting NCT03508570 - Nivolumab With or Without Ipilimumab in Treating Patients With Recurrent or High Grade Gynecologic Cancer With Metastatic Peritoneal Carcinomatosis Phase 1
Not yet recruiting NCT04352894 - Intraoperative ICG Fluorescence Imaging for Peritoneal Carcinomatosis Detection N/A
Terminated NCT01683864 - Randomized Controlled Trial to Prevent Peritoneal Seeding in Gastric Cancer Phase 2/Phase 3
Completed NCT06318793 - Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
Completed NCT05547568 - A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring?
Recruiting NCT04547725 - Complete Cytoreduction Followed by IP and Systemic Chemotherapies for Gastric Cancer With Peritoneal Carcinomatosis N/A
Completed NCT03304210 - PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer Phase 1
Withdrawn NCT03682744 - CAR-T Intraperitoneal Infusions for CEA-Expressing Adenocarcinoma Peritoneal Metastases or Malignant Ascites (IPC) Phase 1
Terminated NCT04047771 - A Phase I Study Evaluating SCB-313 for the Treatment of Subjects With Peritoneal Carcinomatosis Phase 1
Recruiting NCT05623787 - Diagnostic Value of Diffusion-weighted Magnetic Resonance in High-risk Colorectal and Appendiceal Neoplasms N/A
Recruiting NCT05063019 - Role of Magnetic Resonance Enterography for Predicting Peritoneal Cancer Index N/A
Completed NCT02891447 - Heated Mitomycin and Cisplatin During Surgery in Treating Patients With Stomach or Gastroesophageal Cancer Phase 2
Recruiting NCT04231175 - Dedicated MR Imaging vs Surgical Staging of Peritoneal Carcinomatosis in Colorectal Cancer N/A
Not yet recruiting NCT04734691 - Second Line Oxaliplatin Based Chemotherapy Alone Versus Oxaliplatin Based PIPAC and Chemotherapy in Colorectal Peritoneal Carcinomatosis : A Phase II Randomize Mutli-centric Study Phase 2
Recruiting NCT04108936 - Longitudinal Study of CRS/HIPEC for Peritoneal Carcinomatoses
Completed NCT02604784 - Study of Efficacy and Safety of Laparoscopic Intra-abdominal Chemotherapy (PIPAC) Performed in Patients With Peritoneal Carcinomatosis From Colorectal, Ovarian, Gastric Cancer and Primary Peritoneal Tumors Phase 1/Phase 2
Completed NCT01764789 - Stress Reduction in Improving Quality of Life in Patients With Recurrent Gynecologic or Breast Cancer N/A