Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03237507

Enrollment

110

Registered

2017-08-02

Start date

2017-07-01

Completion date

2020-06-01

Last updated

2017-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage IV Gastric Cancer With Metastasis

Brief 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

Interventions

DRUGS-1

40-60mg/m\^2 bid, days 1-14, oral，every 3 weeks.

DRUGoxaliplatin

100mg/m\^2 days 1，intravenous infusion, every 3 weeks.

DEVICEHyperthermic Intraperitoneal

hyperthermic intraperitoneal chemoperfusion

DRUGPaclitaxel

intraperitoneal perfusion

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
PFS: Progression Free Survival	through study completion, an average of 1 year	time from enrollment to disease progression or death

Secondary

Measure	Time frame	Description
OS:overall survival	3 years	time from enrollment to death
Safety	3 years	measured by recording the subjects' Adverse Events according to CTCAE 4.03

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026