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.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Metastases
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the safety and feasibility of the intervention, measured by
the percentage of overall surgical complications
Secondary outcome
Secondary outcomes are mortality, postoperative recovery, quality of life,
disease free and overall survival
Background summary
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, therefor some patients go abroad to receive this treatment.
Study 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.
Intervention
Hyperthermic Intraperitoneal Chemotherapy and Cytoreductive Surgery.
Study burden and risks
The additional burden for the patient consists of HIPEC and CS.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 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.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Histologically proven adenocarcinoma of the stomach.
- Surgical resectable carcinoma (T1-4b, N1-3) (table 1)
- Pathological proven peritoneal metastases
- Peritoneal Cancer Index (PCI) *12
- European Clinical Oncology Group (ECOG) performance status 0,1 or 2
- Age * 18
- Written informed consent
Exclusion criteria
- Distant metastases other than peritoneal metastases
- Siewert type I/II gastro-esophageal junction tumor.
- Peritoneal carcinomatosis as a presentation of recurrent disease
- Pregnancy
- Contraindication to cisplatin (e.g. hypersensitivity, HIV infection and inadequate bone marrow, hepatic or renal function)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-002595-27-NL |
| CCMO | NL58258.041.16 |