Chemotherapy for Potentially Resectable Locally Advanced Esophagogastric Junction Carcinoma

Anyang Tumor Hospital

Status: Unknown

Conditions: Esophagogastric Junction Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT03211377

TOTMSEJ1701

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

120 participants in 3 patient groups

neoadjuvant therapy group

Description:

Preoperation chemotherapy treatment for patients up to four cycles

adjuvant therapy

Description:

Postoperation chemotherapy treatment for patients up to six cycles

Perioperative therapy

Description:

Preoperation chemotherapy treatment for patients up to four cycles and postoperation chemotherapy up to six cycles