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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
| RenJi Hospital | OTHER |
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Fudan University |
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Target population:locally advanced gastric adenocarcinoma (LAGC, cT2~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.
Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.
Secondary objectives:
Trial design:This is a multicenter, single arm, open-label, phase II study to evaluate the efficacy and safety of Oxaliplatin plus capecitabine(XELOX) in the perioperative treatment of locally advanced gastric adenocarcinoma in combination with D2 resection.
Treatment plan:Patients will be given the perioperative chemotherapy as below once recruited:Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ,bid,d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week)Oxaliplatin:130mg/m2, iv infusion over 2h,d1,every 3 weeks.
Number of subjects:50 patients.Number of centers 5 sites, which have the high volume of gastric operations in China, more than 500 per year.
Disease specific inclusion criteria:
Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
General inclusion criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XELOX | Experimental | Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XELOX | Drug | Patients will be given the perioperative chemotherapy as below once recruited: Capecitabine :500 mg tablets(Roche) Oxaliplatin:50mg/10ml(according to daily practice in each center) Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow: Capecitabine 1000 mg/m2 ,orally taken 30 minutes after meal, bid , d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week) Oxaliplatin:130mg/m2, iv infusion over 2h,d1,every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| the response rate of XELOX in the neoadjuvant setting of LAGC | the response rate evaluation will be based on tumor assessment with follow-up, including chest and upper-abdominal During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after)., brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur. | 6 months after the last subject participating in |
| Measure | Description | Time Frame |
|---|---|---|
| the progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT2-3/N+M0,or cT4aN+M0) | progression by the evidence of CT/MRI scan at each evaluation at neoadjuvant period or follow-up time after surgery;During preoperative treatment period, CT scan will be performed every 6 -8 weeks (2 cycles after).After syrgery, CT scan will be planned every 6 months, brain MRI and bone scan (ECT) will be performed if any suspected symptoms occur. |
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Inclusion Criteria:
Exclusion Criteria:
Any previous palliative, adjuvant or neoadjuvant chemotherapy and/or radiotherapy. Prior treatment for locally advanced or metastatic gastric cancer. Any metastatic disease will render patient ineligible according to AJCC staging manual.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tianshu Liu, Doctor | Contact | +861368 1973 996 | liu.tianshu@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Tianshu Liu, Doctor | Medical oncology Shanghai zhongshan hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Affiliated to Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31239311 | Derived | Yu Y, Fang Y, Shen Z, Wang Y, Yan M, Cao H, Liu Y, Wang X, Cui Y, Liu F, Chen W, Li W, Li Q, Jiang H, Sun Y, Liu T. Oxaliplatin plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma in Combination with D2 Gastrectomy: NEO-CLASSIC Study. Oncologist. 2019 Oct;24(10):1311-e989. doi: 10.1634/theoncologist.2019-0416. Epub 2019 Jun 25. |
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| ID | Term |
|---|---|
| C519688 | XELOX |
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| OTHER |
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| 42 months after the last subject participating in |
| percentage of pathological response | After surgery,the pathological response will be measured by the pathologist for every Operation patient. | 10 months after the last subject participating in |
| Percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments | Adverse events and clinical laboratory tests will be recorded by CTCAE (version 4.0) during the whole treatment period. | 1 month after the last date of treatment |
| Overall survival | During the OS follow-up, out-patient clinic and telephone visit will be done every 3 months for the first two years, and every 6 months after two years. | 3 years after the last subject participating in |
| QOL during the whole period of treatment | These assessment will be evaluated at every evaluation. | 1 years after the last date of treatment |