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

Phase Ⅱ Study of S-1 Combined Cisplatin Hyperthermic Intraperitoneal Chemotherapy for Palliative Operation Gastric Cancer of Stage IV Limited Peritoneal Metastasis

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)

Study Overview

• Status: Unknown
• Conditions: Stage IV Gastric Cancer
• Intervention / Treatment: Drug: S-1 plus cisplatin HIPEC

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 029
      • Recruiting
      • IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University
      • Contact: Lina Liu; Phone Number: 029-84777631; Email: tangduec@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: S-1 plus cisplatin HIPEC; 8 cycles of hyperthermic intraperitoneal chemotherapy (cisplatin) and S-1(oral) were performed after palliative operation gastric cancer of stage IV limited peritoneal metastasis. HIPEC was conducted in d1 and d3: Normal saline 2000ml-5000ml, Cisplatin 60mg/m^2, 43°C, 60min. every 3 weeks. S-1: 40-60mg/m^2 bid, days 1-14, every 3 weeks.Subjects should be given maximum 8 cycles, or progression/intolerance.

Drug: S-1 plus cisplatin HIPEC; Using cisplatin in HIPEC plus oral S-1; Other Names: hyperthermic intraperitoneal chemoperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS: Progression Free Survival	from randomization to disease progression or death	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS: Overall Survival	from randomization to death from any cause	5 years
Safety as measured by recording the subjects' Adverse Events from randomization to termination	Record the subjects' AEs from randomization to termination	2 years

Collaborators and Investigators

• Sponsor: Tang-Du Hospital
• Investigators: Principal Investigator: Helong Zhang, Professor, Tang-Du Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: November 11, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 14, 2014

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 13, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Antineoplastic Agents; Cisplatin
• Other Study ID Numbers: TDCCC006