Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

Harbin Medical University

Status: Unknown

Conditions: Stage IV Gastric Cancer With Metastasis

Treatments: Drug: S-1; Device: Hyperthermic Intraperitoneal; Drug: oxaliplatin; Drug: Paclitaxel

Study type: Observational

Funder types: Other

Identifiers

NCT03237507

TOTPMSG1602

Details and patient eligibility

About

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

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

110 participants in 2 patient groups

Chemotherapy Group

Description:

chemotherapy treatment（S-1 and Oxaliplatin） for patients until disease progress

Treatment:

Drug: oxaliplatin

Drug: S-1

Chemotherapy plus HIPEC Group

Description:

Hyperthermic Intraperitoneal chemoperfusion（HIPEC）with Paclitaxel more than 2 cycles and plus chemotherapy

Treatment:

Drug: Paclitaxel

Device: Hyperthermic Intraperitoneal

Drug: oxaliplatin

Drug: S-1