Stomach Neoplasms Clinical Trial
Official title:
The Study of Intraperitoneal Docetaxel Plus S-1 for Malignant Ascites Due to Far Advanced Gastric Cancer
This is a clinical Study to evaluate the effect, survival benefit and safety of intraperitoneal docetaxel combined with oral S-1 for advanced gastric cancer with malignant ascites.
Peritoneal metastasis(PM) is common in advanced gastric cancer and associated with a poor
prognosis. The median survival time is 3 to 4 months and even shorter in the patients with
malignant ascites. Systemic chemotherapy is considered to be less effective against
peritoneal metastasis (PM) due to the existence of the blood-peritoneal barrier (BPB), which
inhibits the movement of drugs from systemic circulation to the peritoneal cavity.
S-1 is one kind of oral fluoropyrimidine derivatives and has been reported to be effective
on PM. Docetaxel (DTX) has a pharmacokinetic advantage after intraperitoneal(IP)delivery
which is hundreds of times higher than systemic administration. The use of S-1 and docetaxel
has been studied in some phase II trials. Fujiwara and Fushida reported the usefulness of IP
docetaxel combined with oral S-1 regimen in gastric cancer with PM respectively,the median
survival time can exceed 16 months and one year survival rate was over 70%. Therefore, the
investigators suppose IP docetaxel and oral S-1 can also be effective for gastric cancer
with malignant ascites and start this study.
This is a single center, open-label, prospective clinical trial. Patients with histological
proven gastric cancer with ascites, who fulfill the inclusion and exclusion criteria, can be
recruited in this study. Patients will be firstly received laparoscopic exploration for
Peritoneal Cancer Index (PCI)score, extraction of 100ml ascites for cytology examination,
and one peritoneal access port is implanted in the subcutaneous space of the lower abdomen.
Then patients were treated with chemotherapy on the first day after operation, the regimen
as follows: DTX is administered IP at a dose of 60 mg/m2 on day 1. DTX is diluted in 1 litre
normal saline and administered through the implanted peritoneal access port over 1 hour. S-1
was administered orally twice daily at a dose of 80 mg/m2 per day for 14 consecutive days,
followed by 7 days of rest. The treatment course will be repeated every three weeks until
observation of disease progression or unacceptable toxicity. Before each intraperitoneal
chemotherapy, investigators extract 50-100 ml ascites for cytology pathologic examination,
the abdominal CT will be reviewed after every three course to evaluate the volume of
ascites.
The volume of ascites before and after therapy, PCI scores, ascites cytology results,
complications, side effects and conditions of survival state and follow-up will be recorded
and analyzed to evaluate the effect, survival benefit and safety of this study.
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