This study has been transitioned to CTIS with ID 2023-510159-53-01 check the CTIS register for the current data. The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms malignant and unspecified
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study endpoint is overall survival. The hypothesis is that the median
overall survival of the patients treated according to protocol in the
experimental arm is 12 months, as compared to a median overall survival of 4
months in the standard arm.
Secondary outcome
- To compare the progression free survival between gastric cancer patients with
limited peritoneal carcinomatosis and/ or tumour positive peritoneal cytology
treated with gastrectomy, cytoreductive surgery and HIPEC and those treated
with the current standard treatment, i.e. palliative systemic chemotherapy.
- To study treatment-related toxicity in gastric cancer patients with limited
peritoneal carcinomatosis and/ or tumour positive peritoneal cytology treated
with gastrectomy, cytoreductive surgery and HIPEC.
- To compare the costs and health benefits of a gastrectomy in combination with
cytoreductive surgery and HIPEC, to the costs and health benefits of standard
palliative systemic chemotherapy in patients with limited peritoneal
carcinomatosis and/ or tumour positive peritoneal cytology.
- To identify genetic profiles related to tumour response in gastric cancer
patients with limited peritoneal carcinomatosis and/ or tumour positive
peritoneal cytology. (Optional)
Background summary
For gastric cancer patients with peritonitis carcinomatosa palliative systemic
chemotherapy is the standard treatment in the Netherlands. There are no
potentially curative treatment options. Peritoneal carcinomatosis, in contrast
to lymphatic and haematogenous dissemination, should be regarded as
locoregional extension of disease. Administering chemotherapeutic drugs
directly into the peritoneal cavity has an advantage over systemic chemotherapy
since high concentrations of cytotoxic drugs can be delivered directly into the
peritoneal cavity with little systemic toxicity. The combination of
intraperitoneally administered chemotherapy with a total gastrectomy and
peritonectomy has shown promising results in gastric cancer patients in Asia.
As with other gastric cancer issues, the results obtained in Asian patients can
not be extrapolated directly to Western patients.
Study objective
This study has been transitioned to CTIS with ID 2023-510159-53-01 check the CTIS register for the current data.
The primary aim of this study is to compare the overall survival between
gastric cancer patients with limited peritoneal carcinomatosis and/ or tumour
positive peritoneal cytology treated with gastrectomy, cytoreductive surgery
and hyperthermic intra-peritoneal chemotherapy (HIPEC) and those treated with
the current standard treatment, i.e. systemic palliative chemotherapy.
Study design
This is a randomised controlled multicentre two-armed phase III trial.
Intervention
Patients will be randomised (1:1) between palliative systemic chemotherapy
(standard treatment) and gastrectomy combined with cytoreductive surgery and
HIPEC (experimental treatment).
Study burden and risks
In the experimental treatment arm patients will be admitted for surgery.
Postoperative complications may occur (e.g. bleeding, wound infection,
pneumonia, ileus, anastomotic leakage). Also, toxicities related to the
chemotherapeutic agents can occur. In both groups a maximum of 8 blood samples
will be taken. All patients will be asked to complete quality of life
questionnaires at 6 moments in time. All patients will be seen at the
outpatient clinic once every 3 months for 1.5 years, and every 6 months
thereafter.
Plesmanlaan 121
Amsterdam 1066CX
NL
Plesmanlaan 121
Amsterdam 1066CX
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- cT3-cT4 adenocarcinoma (or undifferentiated carcinoma) of the stomach,
considered to be resectable
- Limited peritoneal carcinomatosis (PCI <7) and/ or tumour positive peritoneal
cytology (proven by laparoscopy or laparotomy)
- Absence of disease progression during systemic treatment (prior to inclusion)
- WHO performance status 0-2
- Adequate bone marrow, hepatic and renal function
Exclusion criteria
- Distant metastases or small bowel dissemination
- Recurrent gastric cancer
- Prior resection of the primary gastric tumour
- Non-synchronous peritoneal carcinomatosis
- Current other malignancy (other than cervix carcinoma and basalioma)
- Hepatitis B or C, known HIV infection or an uncontrolled infectious disease
- Recent myocardial infarction (< 6 months) or unstable angina
- Uncontrolled diabetes mellitus
- Pregnancy or breast feeding
- Any medical condition that is considered to interfere with study procedures
and/or would jeopardize safe treatment
- Known hypersensitivity for any of the applied chemotherapeutic agents and/or
their solvents
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 |
|---|---|
| EU-CTR | CTIS2023-510159-53-01 |
| EudraCT | EUCTR2015-005695-15-NL |
| ClinicalTrials.gov | NCT03348150 |
| CCMO | NL56123.031.15 |