Advanced Gastric Adenocarcinoma
Conditions
Keywords
Gastric adenocarcinoma, HIPEC, Paclitaxel, Oxaliplatin, Capecitabine
Brief summary
The purpose of this study is to study the efficacy of hyperthermic intraperitoneal chemotherapy in the treatment of patients with locally advanced gastric cancer after radical gastrectomy with D2 lymphadenectomy. It is a multicentric and randomised phase III trial.
Interventions
PROCEDURED2 lymphadenectomy
The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
PROCEDURESystemic chemotherapy
PROCEDUREHIPEC
Sponsors
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18 \< age ≤ 65 years old * Male or Non pregnant female * The Eastern Cooperative Oncology Group (ECOG) status ≤ 2 * Histologically diagnosed as T4 gastric adenocarcinoma (determined from data obtained by endoscopic ultrasound or CT scan) * Have not received cytotoxic chemotherapy, radiotherapy or immunotherapy * White blood cells \> 4,000/mm3 * neutrophils ≥ 1,500/mm3 * platelets ≥ 100,000/mm3 * hemoglobin\>9g/l * Alanine transaminase (ALT) and aspartate aminotransferase (AST) \< or = 2.5 times upper limit of nominal (ULN) * total bilirubin (TBIL) \< 1.5 times ULN * serum creatinine \< 1 times ULN * Having given written informed consent prior to any procedure related to the study
Exclusion criteria
* Existence of macroscopic peritoneal implants * Prior malignant tumors with detectable signs of recurrence or distant metastasis * Poorly controlled disease e.g. atrial fibrillation, stenocardia, cardiac insufficiency, persistent hypertension despite medicinal treatment, ejection fraction\<50% * Receiving other cytotoxic chemotherapy * High grade of intra-abdominal adhesions * Contraindication to any therapy contained in this regimen specific to the study Without given written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 5 years | From the date of surgery to the date of death or to the end of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 5 years | From the date of surgery to the date of recurrence or to the end of follow-up |
| Locoregional-free survival | 5 years | From the date of surgery to the date of locoregional recurrence or to the end of follow-up |
| Hepatic metastases-free survival | 5 years | From the date of surgery to the date of recurrence or to the end of follow-up |
Countries
China
Contacts
Primary Contactzhiyuan fang, Ph.D
Outcome results
None listed