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

Stage IV Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02291211
• Other study ID #: TDCCC006
• Status: Recruiting
• Phase: Phase 2
• First received: November 11, 2014
• Last updated: November 13, 2014
• Start date: September 2014
• Est. completion date: December 2016

Study information

• Verified date: September 2014
• Source: Tang-Du Hospital
• Contact: Helong Zhang, Professor
• Phone: 029-87777225
• Email: cnxazhl[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stage IV Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• S-1 plus cisplatin HIPEC
Using cisplatin in HIPEC plus oral S-1

Locations

Country	Name	City	State
China	IEC of Insititution for National Drug Clinical Trials,Tangdu Hospital,Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Tang-Du Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS: Progression Free Survival	from randomization to disease progression or death	2 years	No
Secondary	OS: Overall Survival	from randomization to death from any cause	5 years	No
Secondary	Safety as measured by recording the subjects' Adverse Events from randomization to termination	Record the subjects' AEs from randomization to termination	2 years	Yes