Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

Stage IV Gastric Cancer With Metastasis Clinical Trial

Official title:

Prospective and Non-interventional Study on Peritoneal Metastasis of Stage IV Gastric Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03237507
• Other study ID #: TOTPMSG1602
• Status: Active, not recruiting
• Phase: N/A
• First received: July 31, 2017
• Last updated: July 31, 2017
• Start date: July 1, 2017
• Est. completion date: June 1, 2020

Study information

• Verified date: July 2017
• Source: Harbin Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a non-interventional study，aim to observe the safety and efficiency of different treatment regimen for peritoneal metastasis of Stage IV gastric cancer in the real world

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 = age

• Patients with histologically confirmed gastric cancer or gastroesophageal junction adenocarcinoma, stage IV with peritoneal metastasis

• Didn't received any prior systemic chemotherapy

• Signed informed consent

Exclusion Criteria:

• History of hypersensitivity to fluoropyrimidines, Tegafur,Gimeracil and Oteracil Potassium Capsules , capecitabine, oxaliplatin or the ingredients of this product

• Pregnancy or lactation women,

• Inadequate hematopoietic function: WBC?3,500/mm3; ANC?1,500/mm3; Platelet?80,000/mm3

• Inadequate organ function which is defined as below:

Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN); serum creatinine > 1.5 mg/dL, and Ccr > 60 ml/min (estimated by Cockcroft-Gault formulation);

• Symptomatic peripheral neuropathy

• Receiving a concomitant treatment with other fluoropyrimidines

• Fluoropyrimidines (DPD) congenital absence

• Other Situations which physicians suggesting are inadaptable for enrollment

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Stage IV Gastric Cancer With Metastasis
• Stomach Neoplasms

Intervention

Drug:
• S-1
40-60mg/m^2 bid, days 1-14, oral,every 3 weeks.
• oxaliplatin
100mg/m^2 days 1,intravenous infusion, every 3 weeks.

Device:
• Hyperthermic Intraperitoneal
hyperthermic intraperitoneal chemoperfusion

Drug:
• Paclitaxel
intraperitoneal perfusion

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS: Progression Free Survival	time from enrollment to disease progression or death	through study completion, an average of 1 year
Secondary	OS:overall survival	time from enrollment to death	3 years
Secondary	Safety	measured by recording the subjects' Adverse Events according to CTCAE 4.03	3 years