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Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03211377
Enrollment
120
Registered
2017-07-07
Start date
2017-03-29
Completion date
2021-04-29
Last updated
2017-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophagogastric Junction Cancer

Brief summary

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

Interventions

None listed

Sponsors

Anyang Tumor Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
disease free survival(DFS)up to 3 yearstime from surgery to disease recurrence or death

Secondary

MeasureTime frameDescription
Overall survival (OS)up to 5 yearstime to death
Adverse events(AE)through study completion, up to 1 yearInvestigators graded all adverse events and toxic effects according to the National Cancer Institute's Common Toxicity Criteria, version 4.03.

Countries

China

Contacts

Primary ContactLi Baozhong
drlibaozhong@163.com0372-2923314

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026