SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer (RESONANCE)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Lin Chen, Chinese PLA General Hospital.
Recruitment status was: Recruiting
Information provided by (Responsible Party):
Lin Chen, Chinese PLA General Hospital
First received: April 4, 2012
Last updated: April 23, 2012
Last verified: April 2012
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.
Drug: Adjuvant Oxaliplatin/S-1（SOX）
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase III, Randomized, Multicenter, Controlled Evaluation of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients
Primary Outcome Measures:
Secondary Outcome Measures:
- response rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: six months ]
Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||September 2014 (Final data collection date for primary outcome measure)
Experimental: Arm A:Neoadjuvant sox
Patients in arm a will receive (N=2-4) cycles of neoadjuvant SOX first, and then standard gastrectomy with D2 lymphadenectomy, and (8-N) cycles of adjuvant SOX adjuvant chemotherapy.
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
Active Comparator: Arm B:Adjuvant SOX
Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.
Drug: Adjuvant 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)
|Ages Eligible for Study:
||20 Years to 75 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed gastric adenocarcinoma
- Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled
- 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
- planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- KPS > 60; ECOG performance status 0-2
- Life expectancy > 6 months
- Age: 20 to 75 years
- No other severe disease and life expectancy less than five years
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
- Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria
- Written informed consent and able to comply with the protocol
- Patient cannot undergo surgery or chemotherapy because of other severe disease
- Be allergic to chemotherapy drugs
- Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
- Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
- Within the last 5 years in patients with a history of other malignant diseases
- Pregnant or breast-feeding women
- 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
- Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
- Patients with a history of peripheral nerve disease
- Patients who get organ transplant
- lack of dihydropyrimidine dehydrogenase (DPD)
- Infection or other disease failure to control
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01583361
|Chinese PLA General Hospital
|Beijing, Beijing, China, 100853 |
|Contact: Tao Li, MD,PhD 0086-10-66938328 email@example.com |
||Lin Chen, Chief of GI Surgeon, Chinese PLA General Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||April 4, 2012
||April 23, 2012
Keywords provided by Lin Chen, Chinese PLA General Hospital:
chemotherapy before and after surgery
disease free survival
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 23, 2017
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases