SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer

Phase 3

• Conditions: Gastric Adenocarcinoma
• Interventions: Drug: Oxaliplatin+S-1; Drug: Adjuvant Oxaliplatin/S-1（SOX）

• Registration Number: NCT01583361
• Lead Sponsor: Lin Chen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-23
• Last Update Submitted: 2012-04-23
• Study First Posted: 2012-04-24
• Last Update Posted: 2012-04-24
• Primary Completion: 2014-09
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 772

Inclusion Criteria

1. Histologically confirmed gastric adenocarcinoma

2. Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled

3. 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

4. planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy

5. KPS > 60; ECOG performance status 0-2

6. Life expectancy > 6 months

7. Age: 20 to 75 years

8. No other severe disease and life expectancy less than five years

9. 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

10. Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria

11. Written informed consent and able to comply with the protocol

Exclusion Criteria

1. Patient cannot undergo surgery or chemotherapy because of other severe disease
2. Be allergic to chemotherapy drugs
3. Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
4. Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
5. Within the last 5 years in patients with a history of other malignant diseases
6. Pregnant or breast-feeding women
7. 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
8. Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
9. Patients with a history of peripheral nerve disease
10. Patients who get organ transplant
11. lack of dihydropyrimidine dehydrogenase (DPD)
12. Infection or other disease failure to control

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A:Neoadjuvant sox	Oxaliplatin+S-1	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.
Arm B:Adjuvant SOX	Adjuvant Oxaliplatin/S-1（SOX）	Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.

Primary Outcome Measures

Name	Time	Method
disease free survival	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.

Secondary Outcome Measures

Name	Time	Method
response rate	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	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	six months	Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China