Gastric Adenocarcinoma
Conditions
Keywords
two arms, D2 lymphadenectomy, chemotherapy before and after surgery, disease free survival
Brief summary
This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy. The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.
Interventions
DRUGOxaliplatin+S-1
S-1: 40\ 60mg bid，po, d1\ 14 （S-1：BSA \<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA\>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1
DRUGAdjuvant Oxaliplatin/S-1（SOX）
S-1：40\ 60mg bid，d1\ 14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)
Sponsors
Lin Chen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Histologically confirmed gastric adenocarcinoma 2. Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled 3. All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stage classification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients can be enrolled 4. planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy 5. KPS \> 60; ECOG performance status 0-2 6. Life expectancy \> 6 months 7. Age: 20 to 75 years 8. No other severe disease and life expectancy less than five years 9. 7 days before enrolled, baseline data should be finished including: * Granulocyte count ≥ 1.5×109/L; * platelet count ≥ 100×109/L; * Hemoglobin ≥ 90g/L; * hepatic \< 1.5×ULN; * total bilirubin ≤ 1.0×ULN; * creatinine \< 1.5×ULN; * PT-INR/PTT \< 1.7× ULN 10. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria 11. Written informed consent and able to comply with the protocol
Exclusion criteria
1. Patient cannot undergo surgery or chemotherapy because of other severe disease 2. Be allergic to chemotherapy drugs 3. Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled 4. Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer 5. Within the last 5 years in patients with a history of other malignant diseases 6. Pregnant or breast-feeding women 7. Severe heart disease like symptoms of coronary heart disease, New York Heart Association (NYHA) grade II or worse congestive heart failure or cardiac arrhythmia having medications or myocardial infarction within the last 12 months 8. Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb 9. Patients with a history of peripheral nerve disease 10. Patients who get organ transplant 11. lack of dihydropyrimidine dehydrogenase (DPD) 12. Infection or other disease failure to control
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| disease free survival | three years | SOX regimen as Neoadjuvant chemotherapy for AJCC II-III gastric cancer patients is superior than postoperative SOX after D2 surgery.Disease free survival is defined as time of surgery to recurrence or death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| response rate | 3 months | For neoadjuvant chemotherapy patients,response rate will be evaluated according to RECIST 1.1 criteria after at least 2 cycles of SOX chemotherapy.CT scan is required to every patient. |
| overall survival | five years | Neoadjuvant chemotherapy of SOX is superior than postoperative SOX after D2 dissection in AJCC II-III gastric cancer patients.Overall survival is defined as the time of randomization to death. |
| safety | six months | Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria. |
Countries
China
Contacts
Primary ContactTao Li, MD,PhD
Outcome results
None listed