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Trial Title:
SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer
NCT ID:
NCT01583361
Condition:
Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Oxaliplatin
Conditions: Keywords:
two arms
D2 lymphadenectomy
chemotherapy before and after surgery
disease free survival
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Oxaliplatin+S-1
Description:
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
Arm group label:
Arm A:Neoadjuvant sox
Other name:
Oxaliplatin(Sanofi-aventis)
Other name:
S-1(Taiho)
Intervention type:
Drug
Intervention name:
Adjuvant Oxaliplatin/S-1（SOX）
Description:
S-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)
Arm group label:
Arm B:Adjuvant SOX
Other name:
Oxaliplatin(Sanofi-aventis)
Other name:
S-1(Taiho)
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese PLA General Hospital
Address:
City:
Beijing
Zip:
100853
Country:
China
Status:
Recruiting
Contact:
Last name:
Tao Li, MD,PhD
Phone:
0086-10-66938328
Email:
litbj301@sina.com
Start date:
March 2012
Completion date:
January 2017
Lead sponsor:
Agency:
Lin Chen
Agency class:
Other
Source:
Chinese PLA General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01583361
