Neoadjuvant SLOT Versus SOX in Patients With Locally Advanced, Resectable Gastric/Esophagogastric Junction (EGJ) Cancer
Phase 3
- Conditions
- Gastric Adenocarcinoma
- Interventions
- Drug: Docetaxel;oxaliplatin;s1Drug: oxaliplatin;s1
- Registration Number
- NCT02512380
- Lead Sponsor
- Chinese Academy of Medical Sciences
- Brief 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.
- Detailed Description
Two arms, phase 3 study of neoadjuvant S1, oxaliplatin, and docetaxel (SLOT) versus S1, oxaliplatin(SOX) in patients with locally advanced, resectable gastric/esophagogastric junction (EGJ) cancer. 380 Patients will be enrolled in this trial. The primary objective of this study is to determine the 5-year survival of the two arms.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 380
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SLOT group Docetaxel;oxaliplatin;s1 4 cycles preoperative chemotherapy with Docetaxel+oxaliplatin+s1 . Gastric resection. 6 cycles adjuvant chemotherapy with sequential oxaliplatin+s1 or oxaliplatin+s1,then s1 for 6 months。 SOX group oxaliplatin;s1 3 cycles preoperative chemotherapy with oxaliplatin+s1. Gastric resection. 4 cycles adjuvant chemotherapy with sequential oxaliplatin+s1
- Primary Outcome Measures
Name Time Method 5 year overall survival 6 years
- Secondary Outcome Measures
Name Time Method 3 year relapse free survival 5 years Surgical complete resection rate (R0) 2.5 year Pathological response rate 2.5 year
Trial Locations
- Locations (1)
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
🇨🇳Beijing, China