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Trial Title:
S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis
NCT ID:
NCT02291211
Condition:
Stage IV Gastric Cancer
Conditions: Official terms:
Stomach Neoplasms
Cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
S-1 plus cisplatin HIPEC
Description:
Using cisplatin in HIPEC plus oral S-1
Arm group label:
S-1 plus cisplatin HIPEC
Other name:
hyperthermic intraperitoneal chemoperfusion
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
Address:
City:
Xi'an
Zip:
029
Country:
China
Status:
Recruiting
Contact:
Last name:
Lina Liu
Phone:
029-84777631
Email:
tangduec@126.com
Start date:
September 2014
Completion date:
December 2016
Lead sponsor:
Agency:
Tang-Du Hospital
Agency class:
Other
Source:
Tang-Du Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT02291211