Gastric Adenocarcinoma
Conditions
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.
Interventions
DRUGDocetaxel;oxaliplatin;s1
Docetaxel 60mg/m2 was administered on day 1 of every 14 days.oxaliplatin 85 mg/m2 was administered on day 2 every 14 days. 40-60 mg of oral S-1 according to body-surface area twice a day was given for 10 days every 14 days .
DRUGoxaliplatin;s1
oxaliplatin 100 mg/m2 on day 1 every 21 days.40-60 mg of oral S-1 according to body-surface area twice a day was given for 2 weeks every 21 days .
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5 year overall survival | 6 years |
Secondary
| Measure | Time frame |
|---|---|
| 3 year relapse free survival | 5 years |
| Surgical complete resection rate (R0) | 2.5 year |
| Pathological response rate | 2.5 year |
Other
| Measure | Time frame |
|---|---|
| quality of life questionnaire | 6 year |
Countries
China
Contacts
Primary ContactJing Huang, M.D.
Backup ContactJing Huang, M.D
Outcome results
None listed