Gastric cancer with peritoneal carcinomatosis or positive peritoneal cytology. MedDRA version: 16.0 Level: HLT Classification code 10017812 Term: Gastric neoplasms malignant System Organ Class: 100000004856 MedDRA version: 16.0 Level: PT Classification code 10067093 Term: Intraperitoneal hyperthermic chemotherapy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Eloxatin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: OXALIPLATIN
CAS Number: 61825-94-3
Trade Name: Docetaxel Sandoz
Pharmaceutical Form: Concentrate f
Sponsors
NKI-AvL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Biopsy proven adenocarcinoma of the stomach (including tumours at the oesophagogastric junction provided that the bulk of the tumour is located in the stomach for which the intended surgical treatment is a gastric resection and not a resection of the oesophagus and cardia) • T3-T4 tumour based upon CT-scan and/or EUS results • Tumour positive peritoneal cytology and/or peritoneal carcinomatosis limited to the upper abdominal cavity (above the transverse colon) and/or at the most at one location in the lower abdominal cavity (e.g., Douglas’ pouch, ovarian metastasis, Sister Mary Joseph nodule) confirmed by diagnostic laparoscopy • Age = 18 years • WHO performance status 0-1 • ASA classification I-III • Adequate bone marrow, hepatic and renal function, i.e., minimal acceptable laboratory values at start of the study inclusion: a. ANC = 1.5 x 10^9 /L b. Platelet count = 100 x 10^9 /L c. Serum bilirubin = 1.5 x ULN, and ALAT and ASAT = 2.5 x ULN d. Creatinine clearance = 50 ml/min (measured or calculated by Cockcroft-Gault formula). • Wildtype for DPD*2A • Negative pregnancy test (urine/serum) for female patients of childbearing potential • Life expectancy = 3 months allowing adequate follow up • Able and willing to undergo blood sampling for pharmacokinetics • Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: • Distant metastases (e.g., liver, lung, para-aortic lymph nodes) or small bowel dissemination • Signs of local irresectability • Recurrent gastric cancer • Metachronous peritoneal carcinomatosis • Prior treatment of gastric cancer with systemic anticancer therapy • Pregnancy, breast feeding or active pregnancy ambition • Unreliable contraceptive methods. Patients enrolled in this trial must agree to use a reliable contraceptive method throughout the study • Uncontrolled infectious disease or known Human Immunodeficiency Virus HIV-1 or HIV-2 type • A known history of hepatitis B or C with active viral replication • Recent myocardial infarction (< 6 months) or unstable angina. • Uncontrolled diabetes mellitus • Any medical condition not yet specified above that is considered to possibly, probably or definitely interfere with study procedures, including adequate follow-up and compliance and/or would jeopardize safe treatment • Known hypersensitivity for any of the applied chemotherapeutic agents and/or their solvents
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - postoperative morbidity and mortality - completion of the study protocol - pharmacokinetic parameters (systemic, intraperitoneal fluid concentrations of oxaliplatin and docetaxel) - cytoreductive completeness score - patterns of tumour recurrence - disease free and overall survival;Timepoint(s) of evaluation of this end point: 2 years | — |
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Treatment related toxicity (graded according to the NCI Common Toxicity Criteria version 4.0);Timepoint(s) of evaluation of this end point: 28 days;Main Objective: to study the safety, tolerability and feasibility of gastrectomy combined with cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (HIPEC) after neoadjuvant systemic chemotherapy as primary treatment option for advanced gastric cancer with tumour positive peritoneal cytology (C+) and/or limited peritoneal carcinomatosis (P+).;Secondary Objective: -to determine the maximum tolerated dose of intraperitoneal docetaxel in combination with a fixed dose regimen of intraperitoneal oxaliplatin in gastric cancer patients undergoing gastrectomy combined with CRS and HIPEC after neoadjuvant systemic chemotherapy with DOC or T-DOC in case of HER2-positive tumour -to investigate the pharmacokinetics of HIPEC after gastrectomy and CRS in patients with advanced gastric cancer and peritoneal dissemination -to study the effect of neoadjuvant systemic chemotherapy on peritoneal dissemination from gastric cancer (peritoneal cancer index before and after neoadjuvant chemotherapy). -to identify genetic profiles predictive of tumour response in patients with gastric cancer and peritoneal dissemination undergoing gastrectomy combined with CRS and HIPEC. -to determine the 2-year disease free and overall survival of advanced gastric cancer patients with tumour positive cytology and/or limited peritoneal carcinomatosis treated with CRS and HIPEC. | — |
Countries
Netherlands
Contacts
Public ContactTrial bureau
NKI-AvL
Outcome results
None listed