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

• Sponsor: Tang-Du Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02291211
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arm: 1
• Duration (Months): 27
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Stage IV Gastric Cancer	Drug: S-1 plus cisplatin HIPEC	Phase 2

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2014
• Anticipated Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Dec 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. PFS: Progression Free Survival [2 years]

   from randomization to disease progression or death

Secondary Outcome Measures

1. OS: Overall Survival [5 years]

   from randomization to death from any cause

2. Safety as measured by recording the subjects' Adverse Events from randomization to termination [2 years]

   Record the subjects' AEs from randomization to termination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University	Xi'an	Shaanxi	China	029

Sponsors and Collaborators

• Tang-Du Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tang-Du Hospital
• ClinicalTrials.gov Identifier: NCT02291211
• Other Study ID Numbers: TDCCC006
• First Posted: Nov 14, 2014
• Last Update Posted: Nov 14, 2014
• Last Verified: Sep 1, 2014

• Additional relevant MeSH terms: Stomach Neoplasms; Cisplatin

Study Results

No Results Posted as of Nov 14, 2014