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

History of Changes

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:

MedlinePlus related topics: Cancer Fever

Drug Information available for: Cisplatin

U.S. FDA Resources

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 Gastrointestinal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Neoplasms Neoplasms by Histologic Type	Neoplasms by Site Neoplasms, Glandular and Epithelial Cisplatin Antineoplastic Agents Pharmacologic Actions Radiation-Sensitizing Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015

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