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Oxaliplatin

6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection

S-1 40\~60mg twice daily for 14 days in 3 weeks for totally 16 courses after D2 resection

S-1 plus oxaliplatin

16 courses S-1 single after d D2 resection

S-1 single

Zhiwei Zhou, PHD

Background: It is shown that TS-1 as adjuvant chemotherapy after D2 resection in patients with gastric cancer can improve DFS and OS in one Japanese Trial. And TS-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve more to OS and DFS than single TS-1 after combined with oxaliplatin . This trial is designed to investigate the efficacy and safety of TS-1 plus oxaliplatin versus TS-1 single as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Patients and methods: In this study , patients with histologically confirmed gastric cancer who received D2 resection and staged II or III, aged from 18 to 70 years and with Eastern Cooperative Oncology Group performance status ≤2 and adequate organ function, are randomized 1:1 to oxaliplatin 100mg/m2 on day 1 and TS-1 40\~60mg twice everyday for 14 days in a 21-days cycle for total 6 cycles followed by TS-1 single with the same dose and frequency to the end of the 1st year postoperatively(SOX) , or TS-1 single 40\~60mg twice everyday for 14 days in a 21-days cycle to the end of the 1st year postoperatively (TS-1). The primary end point is overall survival (OS), and secondary end point is disease free survival(DFS) and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.

Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer

A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer

Sun Yat-sen University

Director of Gastric and Pancreatic Surgery,cancer center of Sun Yat-sen U

S-1 80-120mg daily for 14 days in 3 weeks for totally 6 months after D2 resection

S-1 80-120mg daily for 14 days in 3 weeks for totally 1 year after D2 resection

S-1 for 6 months

S-1 for 1 year

The study aims to compare the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

Hypothesis: For gastric patients after D2 resection, S-1 for 6 months shows non-inferiority to S-1 for 1 year in disease free survival(DFS), overall survival (OS) and safety.

It has been identified that S-1 is an effective adjuvant treatment for East Asian patients who have undergone a D2 dissection for locally advanced gastric cancer（GC) in the Japanese Adjuvant Chemotherapy Trial of TS-1（S-1) for Gastric Cancer (ACTS-GC) trail , And S-1 has become one of the standard therapies to these patients. But it is still unknown whether it would improve equally or even more to overall survival(OS) and disease free survival(DFS) than S-1 for 1 year compared with S-1 for 6 months. As a result , An further clinical trail is still needed, This trial is designed to investigate the efficacy and safety of S-1 for 6 months versus S-1 for 1 year as adjuvant chemotherapy after D2 resection in patients with gastric cancer.

In this study, patients histologically confirmed stage II, IIIA or IIIB and who received D2 resection were randomly assigned to receive S-1 for 6 months or S-1 for 1 year. Patients aged from 18 to 75 years and adequate organ function, are randomized 1:1 to S-1 for 6 months and S-1 for 1 year. Both are the 3-week recycle of S-1 (80-120mg per day) for 2 weeks ,followed by 1 week of rest. The primary end point is 3-year DFS, and secondary end point is 5-year OS and safety. Final study analysis will be conducted in the end of the 5th year after the last patient's enrollment.In summary, we hold the hypothesis that S-1 for 6 months is equally effective, safer, and easier to carry out. If possible, there will be a new adjuvant chemotherapy strategy for gastric cancer patients after D2 resection.

To ensure the quality of the study, two interim analyses will be planned at the half and the completion of the study respectively. The DATA and Safety Monitoring Committee will independently review the interim analysis and stop the study ahead of schedule if necessary. Furthermore, to improve the study progress and quality, the in-house interim monitoring will be performed.

Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

A Prospective,Multicentral,Open-label,Randomized,Controlled,Phase III Clinical Trial to Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.

Complications such as Nausea, vomiting, myelosuppression and Liver or kidney function disorder.

Anhui Provincial Hospital

The First Affiliated Hospital of Anhui Medical University

Anqing Municipal Hospital

Yuebei People's Hospital

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangdong Provincial Hospital of Traditional Chinese Medicine

Shenzhen People's Hospital

First Affiliated Hospital of Wannan Medical College

Lishui hospital of Zhejiang University

Fudan University

Professor

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Capecitabine

Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable

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

XELOX

Tianshu Liu, Doctor

Tianshu Liu, doctor

Yiyi yu, Master

1. Target population:locally advanced gastric adenocarcinoma (LAGC, cT2\~3/N+M0,or cT4aN+M0);no previous chemo or radio therapy.
2. Primary objective:Response rate of XELOX in the neoadjuvant setting of LAGC.

   Secondary objectives:
   * The progression free survival (PFS) in the perioperative treatment of locally advanced gastric adenocarcinoma (cT3/N+M0,or cT4aN+M0);
   * percentage of pathological response ; percentage of grade 3 or 4 adverse events as safety profile of perioperative treatments;
   * D2 resection -rate after neoadjuvant chemotherapy of XELOX;
   * Overall survival;
   * QOL during the whole period of treatment.
3. 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.
4. 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.
5. 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.

1. Disease specific inclusion criteria:

   * Histologically documented gastricadenocarcinoma with Lauren classification Clinically diagnosed stage T2-3/N+M0,orT4aN+M0 according to CT/MRI scan, and resectable
   * Measurable disease is required
   * Karnofsky score 80%.
   * Physical condition and adequate organ function to ensure the success of abdominal surgery.
   * Life expectancy ≥12 weeks.
   * Adequate hematological function: Neutrophil count ≥ 1.5 × 109/L, Platelets ≥ 100 × 109/L and Hemoglobin ≥8g/dL .Adequate liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); AST (SGOT) and ALT (SGPT) \< 2.5 × ULN in the absence of liver metastases, or \< 5 × ULN in case of liver metastases. ALP ≤ 2.5 × upper limit of normal (ULN); ALB ≥30g/L.

   Adequate renal function: Serum creatinine ≤ 1.25 x ULN, and creatinine clearance ≥ 60 ml/min.
   * Female subjects should not be pregnant or breast-feeding.
   * No serious concomitant disease that will threaten the survival of patients to less than 5 years.
2. General inclusion criteria:

   * Male or female. Age ≥ 18 years and ≤75 years
   * Written (signed) informed consent.
   * Able to comply with study and follow-up procedures.
   * Good compliance with the treatment plan。
   * Consent to provide tissue sample。

Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma

A Multicenter, Single Arm, Open-label Trial of Oxaliplatin Plus Capecitabine (XELOX) in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma

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.

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.

After surgery，the pathological response will be measured by the pathologist for every Operation patient.

Adverse events and clinical laboratory tests will be recorded by CTCAE (version 4.0) during the whole treatment period.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer	NCT01795027	Gastric Cancer	S-1 plus oxalip... S-1 single	18 Years - 70 Years	Sun Yat-sen University
Compare S-1 for 6 Months to 1 Year as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer Staged II , IIIA or IIIB.	NCT02736552	Gastric Cancer	S-1 for 6 month... S-1 for 1 year	18 Years - 75 Years	Fudan University
Oxaliplatin Plus Capecitabine in the Perioperative Treatment of Locally Advanced Gastric Adenocarcinoma	NCT01880632	Gastric Adenoca...	XELOX	18 Years - 75 Years	Shanghai Zhongshan Hospital
Compare S-1 Plus Oxaliplatin to S-1 as Adjuvant Chemotherapy After D2 Resection in Patients With Gastric Cancer	NCT01795027	Gastric Cancer	S-1 plus oxalip... S-1 single	18 Years - 70 Years	Sun Yat-sen University

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