S-1 Combined Cisplatin HIPEC for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

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