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Cytoreductive Surgery(CRS) Plus Hyperthermic Intraoperative Peritoneal Chemotherapy(HIPC) With Cisplatin to Treat Peritoneal Carcinomatosis From Upper Gastrointestinal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01116791
Recruitment Status : Terminated (Insufficient enrollment in Pancreatic & Biliary arm)
First Posted : May 5, 2010
Last Update Posted : December 2, 2015
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg

Brief Summary:
The majority of patients with upper gastrointestinal cancer, such as gastric, biliary, or pancreatic carcinoma, present with metastatic disease, and have an extremely poor survival, irrespective the type of treatment modality. The aim of the current monocentric phase II study is to evaluate in these patients the effectiveness of cytoreductive surgery (CRS) plus hyperthermic intraoperative peritoneal chemotherapy with cisplatin (HIPC). The study is designed to have at least 80% power to detect a 40% increase in 1-year overall survival common to all strata (gastric-biliary-pancreas) after CRS+HIPC. Over an anticipated period of 2 years, 60 patients will undergo CRS + HIPC. Translational research will quantify perioperative circulating and peritoneal tumour cells, based on real-time RT-PCR for CEA and EpCAM. Plasma concentration of cytokines will be determined for IL-1β, IL-2, IL-6, IL-8, IL-10, IL-12p70, IL-13, IFN-γ, and VEGF at several time-points. Systemic immunological changes will be assessed by flow cytometric quantification of the relative proportions and absolute numbers of B- and T-lymphocytes, NK cells, effector T cells, HLA-DR+ T cells, and regulatory T cells. Gene-expression studies will be performed using Affymetrix HG U133 Plus 2.0 arrays on primary and metastatic tissue samples.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Gastrointestinal Cancer Procedure: Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cytoreductive Surgery Plus Hyperthermic Intraoperative Peritoneal Chemotherapy With Cisplatin to Treat Peritoneal Carcinomatosis From Upper Gastrointestinal Cancer; the HIPCUpp-trial
Study Start Date : July 2010
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever
Drug Information available for: Cisplatin

Arm Intervention/treatment
Experimental: CRS+HIPC
Patients with biliary, gastric, or pancreatic carcinoma and metastatic or recurrent disease confined to the abdominal compartment
Procedure: Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC)
  • CRS is defined as macroscopic tumour removal using surgical resection and/or local ablative therapy (LAT)
  • HIPC is administered immediately after CRS

Primary Outcome Measures :
  1. Overall survival time (OS) following CRS+HIPC (from surgery to cancer-related death) [ Time Frame: 1 year follow-up ]

    Statistical methodology. The study is designed to have at least 80% power to detect a 40% increase in 1-y OS common to all strata (gastric-biliary-pancreas) after CRS+HIPC. The reference percentages 1-y OS are 52%, 37% and 34% for gastric, biliary and pancreatic cancer, respectively. An exponential distribution is assumed for the event times in the study group with a parameter yielding 72.8%, 51.8% and 47.6% 1-y OS in the mentioned strata.

    Cancer-specific survival will be monitored using consecutive CT- and/or MRI-scan every 3 months after CRS+HIPC.

Secondary Outcome Measures :
  1. In-hospital perioperative complications [ Time Frame: up to 24 weeks ]
    The number and type of perioperative complications will be recorded. The therapy-oriented severity grading system (TOSGS) of complications will be used, and complications will be allocated to surgical (SSC) and non-surgical site (NSSC) complications

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Primary or recurrent disease
  • Histological confirmation of primary (or recurrent) and metastatic disease
  • Systemic chemotherapy and/or biological is allowed before and/or after CRS+HIPC
  • Radiotherapy is allowed before or after CRS+HIPC
  • Patients must not have failed prior intraperitoneal platinum-therapy
  • Age between 18 to 75 years
  • Patient Karnofsky performance scale (KPS) > 80 (normal activity with a bit of effort)

Exclusion Criteria:

  • Age < 18 or > 75 years
  • Pregnancy
  • Any malignancy other than biliary, gastric, or pancreatic adenocarcinoma
  • Any metastatic disease outside the abdominal compartment, such as pulmonary or bone metastases
  • Peritoneal carcinomatosis index (PCI) > 20 at the start of CRS
  • Peritoneal residual tumour nodules larger than 2.5 mm after CRS (CCR-2)
  • Clinical relevant ascites
  • More than 3 liver metastases
  • Solitary liver metastasis larger than 5 cm

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 identifier (NCT number): NCT01116791

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University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Baki Topal
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Baki Topal, MD, PhD Universitaire Ziekenhuizen Leuven
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Baki Topal, Professor of Surgery, University Hospital, Gasthuisberg Identifier: NCT01116791    
Other Study ID Numbers: HIPCUpp-trial
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015
Keywords provided by Baki Topal, University Hospital, Gasthuisberg:
cytoreductive surgery
peritoneal chemotherapy
peritoneal metastases
liver metastases
peritoneal carcinomatosis from upper gastrointestinal cancer
Additional relevant MeSH terms:
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Gastrointestinal Neoplasms
Peritoneal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Abdominal Neoplasms
Peritoneal Diseases
Antineoplastic Agents