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Nonintervention Study on Peritoneal Metastasis of Stage IV Gastric Cancer

H

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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