Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

Esophagogastric Junction Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03211377
• Other study ID #: TOTMSEJ1701
• Status: Recruiting
• Phase: N/A
• First received: July 3, 2017
• Last updated: July 7, 2017
• Start date: March 29, 2017
• Est. completion date: April 29, 2021

Study information

• Verified date: June 2017
• Source: Anyang Tumor Hospital
• Contact: Li Baozhong
• Phone: 0372-2923314
• Email: drlibaozhong[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 29, 2021
• Est. primary completion date: March 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esophagogastric Junction Cancer

Locations

Country	Name	City	State
China	Department of science and education	Anyang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Anyang Tumor Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease free survival(DFS)	time from surgery to disease recurrence or death	up to 3 years
Secondary	Overall survival (OS)	time to death	up to 5 years
Secondary	Adverse events(AE)	Investigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 4.03.	through study completion, up to 1 year