Neoadjuvant SLOT Versus SOX in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer

• Status: Unknown status
• Trial end date: 2021-07-01
• Target enrollment: 0
• Participant gender: All

Summary

gastric cancer is a highly aggressive malignancy with a poor overall outcome. The purpose of this study is to evaluate the 5-year survival of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Docetaxel; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically proven gastric or GE junction adenocarcinoma;

• Age: 18 to 70;

• ECOG 0-2;

• Adenocarcinoma of the stomach or GE junction according to staging classification TNM Scannographic: T3-4 N0/N + M0 ;

• Completion of baseline quality of life questionnaire

• Adequate bone marrow functions (ANC ≥ 1,500/ul, blood platelet ≥ 100,000/ul, haemoglobin ≥ 10g/dl);

• Adequate renal functions(serum creatinine ≤ 1.5mg/dl)

• liver functions (serum bilirubin ≤ 1.5UNL, AST/ALT ≤ 3 times(normal value)

• Written informed consent

Exclusion Criteria:

• Previous chemotherapy;

• Active infection requiring antibiotics

• Pregnant, lactating women

• Psychiatric illness, epileptic disorders

• Concurrent systemic illness not appropriate for chemotherapy

• History of other malignancy within 5 years except for non-melanoma skin cancer, cervix in situ carcinoma