SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer (RESONANCE)
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|ClinicalTrials.gov Identifier: NCT01583361|
Recruitment Status : Unknown
Verified April 2012 by Lin Chen, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : April 24, 2012
Last Update Posted : April 24, 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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: Oxaliplatin+S-1 Drug: Adjuvant Oxaliplatin/S-1（SOX）||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||772 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III, Randomized, Multicenter, Controlled Evaluation of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients|
|Study Start Date :||March 2012|
|Estimated Primary Completion Date :||September 2014|
|Estimated Study Completion Date :||January 2017|
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)
- disease free survival [ Time Frame: 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583361
|Contact: Tao Li, MD,PhDfirstname.lastname@example.org|
|Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Tao Li, MD,PhD 0086-10-66938328 email@example.com|