Non-interventional Study to Evaluate Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

Anyang Tumor Hospital1 site in 1 country120 target enrollmentMarch 29, 2017

ConditionsEsophagogastric Junction Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Esophagogastric Junction Cancer
Sponsor: Anyang Tumor Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: disease free survival(DFS)
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

March 29, 2017

End Date

April 29, 2021

Last Updated

8 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Anyang Tumor Hospital

Responsible Party

Sponsor

Eligibility Criteria

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