Malignant Neoplasm of Stomach
Conditions
Brief summary
The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of overall survival.
Detailed description
To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer, patients are randomized into HIPEC group and control group. In HIPEC group, the patients undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu. Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are followed up for 5 years or until death. The trial is designed as a prospective, randomized, open, multicenter and parallel group study.
Interventions
Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
PROCEDURED2 radical gastrectomy
radical gastrectomy with D2 lymphadenectomy
OTHERSOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
OTHERXELOX postoperative chemotherapy
Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Sponsors
Wuhan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Histological proved diagnosis of locally advanced gastric cancer. * No evidence of distant metastases or peritoneal metastases. * Preoperative examination (CT/MRI) demonstrated resectable gastric cancer with T3-T4 stage. * Eligible for radical gastrectomy with D2 lymphadenectomy. * Have not received cytotoxic chemotherapy or radiotherapy. * Written informed consent is obtained prior to commencement of trial treatment.
Exclusion criteria
* Existence of distant metastasis or peritoneal metastasis during surgery (M1). * Any previous chemotherapy or radiotherapy * Active systemic infections * Inadequate cardiac function, renal function, liver function or bone marrow function at the beginning of the trial. * Female patients who are pregnant or breast feeding
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 |
|---|---|
| complication rate | 5 years |
| progression-free survival | 5 years |
| distant metastasis rate | 5 years |
| peritoneal metastasis rate | 5 years |
| local recurrence rate | 5 years |
Countries
China
Outcome results
None listed