MedPath

Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

Conditions
Esophagogastric Junction Cancer
Registration Number
NCT03211377
Lead Sponsor
Anyang Tumor Hospital
Brief Summary

This is a non-interventional study to observe the safety and efficiency of chemotherapy for potentially resectable locally advanced esophagogastric junction

Detailed Description

Not available

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
120
Inclusion Criteria
  • Histologically or cytological proved locally advanced esophagogastric junction cancer
  • ECOG performance status ≦2
  • Stage IIa-IIIc
  • No distant metastasis (M0)
  • Sign in Informed Consent Form
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
disease free survival(DFS)up to 3 years

time from surgery to disease recurrence or death

Secondary Outcome Measures
NameTimeMethod
Adverse events(AE)through study completion, up to 1 year

Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 4.03.

Overall survival (OS)up to 5 years

time to death

Trial Locations

Locations (1)

Department of science and education

🇨🇳

Anyang, Henan, China

© Copyright 2025. All Rights Reserved by MedPath