Clinical trial NCT02291211: S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
Official title: Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage IV Gastric Cancer
Lead sponsor: Tang-Du Hospital
Sponsor class: OTHER
First posted: 2014-11-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the efficacy of S-1 plus cisplatin hyperthermic intraperitoneal chemotherapy for advanced gastric patients of gastric cytoreductive surgery (CRS)

Detailed description: This project is a single-center, open clinical observation the safety and efficacy that stage IV limited peritoneal metastasis of gastric cancer patients accept S-1 plus hyperthermic intraperitoneal chemotherapy . With advanced gastric patients of confined to the peritoneal after CRS as the research object, with progression-free survival and overall survival, adverse events as the end points.

Eligibility criteria: Inclusion Criteria:

* 18 ≤ age ≤ 70 years old
* Patients with histologically confirmed gastric cancer (adenocarcinoma), stage IV (limited to the abdominal cavity), accpeted palliative cytoreductive surgery and no prior chemotherapy, biological therapy or targeted anti-cancer therapy, etc.
* The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
* Having given written informed consent prior to any procedure related to the study
* Expected survival time ≥3 months

Exclusion Criteria:

* Known to have abdominal viscera metastasis of gastric cancer patients
* Inadequate hematopoietic function which is defined as below:

  * white blood cell (WBC) less than 3,500/mm\^3
  * absolute neutrophil count (ANC) less than 1,500/mm\^3
  * platelets less than 80,000/mm\^3
* Inadequate hepatic or renal function which is defined as below:

  * serum bilirubin greater than 2 times the upper limit of normal range
  * alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 times the ULN if no demonstrable liver metastases or greater than 5 times the ULN in the presence of liver metastases
  * blood creatinine level greater than 1.5 times ULN,Creatinine clearance \< 60ml/min
* Receiving a concomitant treatment with other fluoropyrimidine drug or flucytosine drug
* Women who is pregnant or lactating or fertile women of child-bearing potential unless using a reliable and appropriate contraceptive method throughout the treatment period (Including male)
* Psychiatric disorder or symptom that makes participation of the patient difficult
* Myocardial infarction, existing serious or unstable angina, and patients with cardiac insufficiency in 6 months
* Severe complication(s), e.g., paresis of intestines, ileus, radiographically confirmed interstitial pneumonitis or pulmonary fibrosis, glomerulonephritis ,renal failure, poorly-controlled diabetes
* Known DPD deficiency
* Have the history of allograft transplantation
* Conducted the autologous bone marrow transplantation in 4 weeks
* Participate in other clinical trial before the start of this trial in 4 weeks
* Patient compliance is bad or researchers believe that patients are not suitable for this treatment
* Known to have active hepatitis patients
* HER-2-positive patients (ICH3+or FISH+)
* History of severe hypersensitivity reactions to the ingredients of S-1 or Cisplatin

Primary outcomes:
measure: PFS: Progression Free Survival
timeFrame: 2 years
Secondary outcomes:
measure: OS: Overall Survival
timeFrame: 5 years
measure: Safety as measured by recording the subjects' Adverse Events from randomization to termination
timeFrame: 2 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Tang-Du Hospital
name: Helong Zhang, Professor
role: PRINCIPAL_INVESTIGATOR
References: