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

NCT01116791 | Terminated Phase 2

• 1 other identifier: HIPCUpp-trial
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Peritoneal Carcinomatosis; Gastrointestinal Cancer

Keywords

cytoreductive surgery; peritoneal chemotherapy; cisplatin; cancer; gastric; biliary; pancreas; peritoneal metastases; liver metastases; peritoneal carcinomatosis from upper gastrointestinal cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival time (OS) following CRS+HIPC (from surgery to cancer-related death)

  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.

  1 year follow-up

Secondary Outcomes (1)

• In-hospital perioperative complications

  up to 24 weeks

Study Arms (1)

CRS+HIPC

EXPERIMENTAL

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)

Interventions

Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC) PROCEDURE

* CRS is defined as macroscopic tumour removal using surgical resection and/or local ablative therapy (LAT) * HIPC is administered immediately after CRS

CRS+HIPC

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Baki Topal: lead
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, 3000, Belgium

Location

Related Publications (2)

• Topal B, Demey K, Topal H, Jaekers J, Van Cutsem E, Vandecaveye V, Sagaert X, Prenen H. Cytoreductive surgery and Hyperthermic intra-operative peritoneal chemotherapy with Cisplatin for gastric peritoneal Carcinomatosis Monocentric phase-2 nonrandomized prospective clinical trial. BMC Cancer. 2017 Nov 17;17(1):771. doi: 10.1186/s12885-017-3730-6.

  PMID: 29149865 DERIVED

• Janky R, Binda MM, Allemeersch J, Van den Broeck A, Govaere O, Swinnen JV, Roskams T, Aerts S, Topal B. Prognostic relevance of molecular subtypes and master regulators in pancreatic ductal adenocarcinoma. BMC Cancer. 2016 Aug 12;16:632. doi: 10.1186/s12885-016-2540-6.

  PMID: 27520560 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms; Gastrointestinal Neoplasms; Neoplasms

Interventions

Cytoreduction Surgical Procedures; Cisplatin

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Baki Topal, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 5, 2010
• Study Start: July 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 2, 2015

Record last verified: 2015-12

Locations

BE (1)