Cytoreductive Surgery(CRS) Plus Hyperthermic Intraoperative Peritoneal Chemotherapy(HIPC) With Cisplatin to Treat Peritoneal Carcinomatosis From Upper Gastrointestinal Cancer
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ClinicalTrials.gov Identifier: NCT01116791 |
Recruitment Status :
Terminated
(Insufficient enrollment in Pancreatic & Biliary arm)
First Posted : May 5, 2010
Last Update Posted : December 2, 2015
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Condition or disease | Intervention/treatment | Phase |
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Peritoneal Carcinomatosis Gastrointestinal Cancer | Procedure: Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC) | Phase 2 |

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 |

Arm | Intervention/treatment |
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Experimental: CRS+HIPC
Patients with biliary, gastric, or pancreatic carcinoma and metastatic or recurrent disease confined to the abdominal compartment
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Procedure: Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC)
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- 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.
- 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

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 ClinicalTrials.gov identifier (NCT number): NCT01116791
Belgium | |
University Hospitals Leuven | |
Leuven, Belgium, 3000 |
Principal Investigator: | Baki Topal, MD, PhD | Universitaire Ziekenhuizen Leuven |
Responsible Party: | Baki Topal, Professor of Surgery, University Hospital, Gasthuisberg |
ClinicalTrials.gov 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 |
cytoreductive surgery peritoneal chemotherapy cisplatin cancer gastric |
biliary pancreas peritoneal metastases liver metastases peritoneal carcinomatosis from upper gastrointestinal cancer |
Gastrointestinal Neoplasms Carcinoma Peritoneal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Abdominal Neoplasms Peritoneal Diseases Cisplatin Antineoplastic Agents |