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:
Baki Topal
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: December 1, 2015
Last verified: December 2015
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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 |
| Study Completion Date: | December 2015 |
| Primary Completion Date: | December 2015 (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)
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01116791
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
| 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: | December 1, 2015 |
| 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:
|
Gastrointestinal Neoplasms Carcinoma Fever Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Body Temperature Changes Signs and Symptoms Cisplatin Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 27, 2016