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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A:Neoadjuvant sox | Experimental | 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. |
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| Arm B:Adjuvant SOX | Active Comparator | Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxaliplatin+S-1 | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| disease free survival | 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. | three years |
| Measure | Description | Time Frame |
|---|---|---|
| response rate | 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. | 3 months |
| overall survival |
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Inclusion Criteria:
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:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Li, MD,PhD | Contact | 86-10-66938328 | litbj301@sina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38589926 | Derived | Wang X, Lu C, Wei B, Li S, Li Z, Xue Y, Ye Y, Zhang Z, Sun Y, Liang H, Li K, Zhu L, Zheng Z, Zhou Y, He Y, Li F, Wang X, Liang P, Huang H, Li G, Shen X, Ji J, Tang Y, Xu Z, Chen L; RESONANCE study group. Perioperative versus adjuvant S-1 plus oxaliplatin chemotherapy for stage II/III resectable gastric cancer (RESONANCE): a randomized, open-label, phase 3 trial. J Hematol Oncol. 2024 Apr 8;17(1):17. doi: 10.1186/s13045-024-01536-7. |
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| Adjuvant Oxaliplatin/S-1(SOX) | Drug | S-1:40~60mg bid,d1~14 q3W oxaliplatin:130mg/m2,iv drip for 2h,d1,q3W 8 cycles (6 months) |
|
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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.
| five years |
| safety | Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria. | six months |