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

This study has been terminated.
(Insufficient enrollment in Pancreatic & Biliary arm)
Sponsor:
Collaborator:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
Baki Topal, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01116791
First received: May 3, 2010
Last updated: September 16, 2013
Last verified: September 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Overall survival time (OS) following CRS+HIPC (from surgery to cancer-related death) [ Time Frame: 1 year follow-up ] [ Designated as safety issue: No ]

    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:
  • In-hospital perioperative complications [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    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


Enrollment: 34
Study Start Date: July 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116791

Locations
Belgium
University Hospitals Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Baki Topal
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Baki Topal, MD, PhD University Hospitals Leuven
  More Information

No publications provided

Responsible Party: Baki Topal, Professor of Surgery, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01116791     History of Changes
Other Study ID Numbers: HIPCUpp-trial
Study First Received: May 3, 2010
Last Updated: September 16, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Keywords provided by University Hospital, Gasthuisberg:
cytoreductive surgery
peritoneal chemotherapy
cisplatin
cancer
gastric
biliary
pancreas
peritoneal metastases
liver metastases
peritoneal carcinomatosis from upper gastrointestinal cancer

Additional relevant MeSH terms:
Carcinoma
Fever
Gastrointestinal Neoplasms
Body Temperature Changes
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Signs and Symptoms
Cisplatin
Antineoplastic Agents
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014