Gastric Cancer Clinical Trial
Official title:
Cytoreductive Surgery and Intraperitoneal Chemotherapy for Stomach CAncer: a Feasibility Study
Rationale: For patients with peritoneal metastases of gastric origin, there is no consensus
on the optimal treatment strategy. Several Asian and Western studies demonstrated
hyperthermic intraperitoneal chemotherapy (HIPEC) and cytoreductive surgery (CS) to result in
a prolonged survival compared to palliative systemic treatment. Morbidity and mortality rates
of HIPEC and CS appear to be acceptable. In the Netherlands, this treatment is not yet
introduced, therefore patients with peritoneal metastases of gastric origin are precluded
from surgery and will be treated with palliative chemotherapy or best support of care.
Objective: To assess the safety and feasibility of HIPEC and CS in Western patients with
peritoneal metastases of gastric cancer, in terms of morbidity and mortality. Secondary
objective is to determine the effect on survival and recurrence.
Study design: Mono centre prospective phase II single-arm feasibility study.
Study population: Western patients diagnosed with resectable (cT1-4b, N1-3) gastric cancer
with clinical or pathologically proven peritoneal metastases without distant metastases.
Intervention: Hyperthermic Intraperitoneal Chemotherapy (HIPEC) and Cytoreductive Surgery
(CS) with Cisplatin.
Main study parameters/endpoints: Primary outcome is the safety and feasibility of the
intervention, measured by the percentage of overall surgical complications grade ≥3 as stated
by the Common Terminology Criteria for Adverse Events. Secondary outcomes are intraoperative
events, postoperative morbidity and mortality, postoperative recovery, including quality of
life, and disease free- and overall survival.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: The additional burden for the patient mainly consists of HIPEC and
CS.Furthermore, patients will undergo additional staging in order to exclude unresectable
disease, and neoadjuvant chemotherapy regimen (3 drugs) instead of a palliative chemotherapy
regimen (2 drugs). Postoperative care and outpatient visits are performed according to
current protocols on HIPEC and CS for colon cancer and nation-wide protocols on gastric
cancer surgery. The study is associated with a high risk classification. As there is a
potential survival benefit, a small chance for curation and possibly a higher quality of
life, we consider the additional burden and risks justified. This study is designed as a one
group study, which eliminates group relatedness.
n/a
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