Back to resultsSOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer (RESONANCE)
Primary Purpose
Gastric Adenocarcinoma
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Oxaliplatin+S-1
Adjuvant Oxaliplatin/S-1（SOX）
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring two arms, D2 lymphadenectomy, chemotherapy before and after surgery, disease free survival
Eligibility Criteria
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:
- 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
- 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:
- Patient cannot undergo surgery or chemotherapy because of other severe disease
- Be allergic to chemotherapy drugs
- Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
- Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
- Within the last 5 years in patients with a history of other malignant diseases
- Pregnant or breast-feeding women
- 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
- Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
- Patients with a history of peripheral nerve disease
- Patients who get organ transplant
- lack of dihydropyrimidine dehydrogenase (DPD)
- Infection or other disease failure to control
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A:Neoadjuvant sox
Arm B:Adjuvant SOX
Arm Description
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.
Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
safety
Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01583361
Brief Title
SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer
Acronym
RESONANCE
Official Title
Phase III, Randomized, Multicenter, Controlled Evaluation of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
September 2014 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lin Chen
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
two arms, D2 lymphadenectomy, chemotherapy before and after surgery, disease free survival
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
772 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A:Neoadjuvant sox
Arm Type
Experimental
Arm Description
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 Title
Arm B:Adjuvant SOX
Arm Type
Active Comparator
Arm Description
Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin+S-1
Other Intervention Name(s)
Oxaliplatin(Sanofi-aventis), S-1(Taiho)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Adjuvant Oxaliplatin/S-1（SOX）
Other Intervention Name(s)
Oxaliplatin(Sanofi-aventis), S-1(Taiho)
Intervention Description
S-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)
Primary Outcome Measure Information:
Title
disease free survival
Description
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.
Time Frame
three years
Secondary Outcome Measure Information:
Title
response rate
Description
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.
Time Frame
3 months
Title
overall survival
Description
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.
Time Frame
five years
Title
safety
Description
Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.
Time Frame
six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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
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:
Patient cannot undergo surgery or chemotherapy because of other severe disease
Be allergic to chemotherapy drugs
Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
Within the last 5 years in patients with a history of other malignant diseases
Pregnant or breast-feeding women
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
Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
Patients with a history of peripheral nerve disease
Patients who get organ transplant
lack of dihydropyrimidine dehydrogenase (DPD)
Infection or other disease failure to control
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Li, MD,PhD
Phone
86-10-66938328
Email
litbj301@sina.com
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Li, MD,PhD
Phone
0086-10-66938328
Email
litbj301@sina.com
12. IPD Sharing Statement
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SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer
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