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

Gastric Adenocarcinoma Clinical Trial

— RESONANCE  

Official title:

Phase III, Randomized, Multicenter, Controlled Evaluation of S‐1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01583361
• Other study ID #: LCHEN-PLAGH
• Status: Recruiting
• Phase: Phase 3
• First received: April 4, 2012
• Last updated: April 23, 2012
• Start date: March 2012
• Est. completion date: January 2017

Study information

• Verified date: April 2012
• Source: Chinese PLA General Hospital
• Contact: Tao Li, MD,PhD
• Phone: 86-10-66938328
• Email: litbj301[@]sina.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 772
• Est. completion date: January 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Gastric Adenocarcinoma

Intervention

Drug:
• Oxaliplatin+S-1
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
• 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)

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Lin Chen

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	overall survival	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	No
Secondary	safety	Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.	six months	Yes