TerminatedPhase 2

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

Stopped: Insufficient enrollment in Pancreatic \& Biliary arm

Belgium34 participantsStarted 2010-07

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 year follow-up

Trial details

NCT IDNCT01116791

SponsorBaki Topal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-12

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