SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer (RESONANCE)
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ClinicalTrials.gov Identifier: NCT01583361 |
Recruitment Status : Unknown
Verified April 2012 by Lin Chen, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : April 24, 2012
Last Update Posted : April 24, 2012
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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.
Condition or disease | Intervention/treatment | Phase |
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Gastric Adenocarcinoma | Drug: Oxaliplatin+S-1 Drug: Adjuvant Oxaliplatin/S-1(SOX) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 772 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III, Randomized, Multicenter, Controlled Evaluation of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients |
Study Start Date : | March 2012 |
Estimated Primary Completion Date : | September 2014 |
Estimated Study Completion Date : | January 2017 |
Arm | Intervention/treatment |
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Experimental: Arm A:Neoadjuvant sox
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.
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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
Other Names:
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Active Comparator: Arm B:Adjuvant SOX
Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later.
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Drug: 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)
Other Names:
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- disease free survival [ Time Frame: 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.
- response rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: six months ]Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.
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Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01583361
Contact: Tao Li, MD,PhD | 86-10-66938328 | litbj301@sina.com |
China, Beijing | |
Chinese PLA General Hospital | Recruiting |
Beijing, Beijing, China, 100853 | |
Contact: Tao Li, MD,PhD 0086-10-66938328 litbj301@sina.com |
Responsible Party: | Lin Chen, Chief of GI Surgeon, Chinese PLA General Hospital |
ClinicalTrials.gov Identifier: | NCT01583361 |
Other Study ID Numbers: |
LCHEN-PLAGH |
First Posted: | April 24, 2012 Key Record Dates |
Last Update Posted: | April 24, 2012 |
Last Verified: | April 2012 |
two arms D2 lymphadenectomy chemotherapy before and after surgery disease free survival |
Adenocarcinoma Stomach Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Oxaliplatin Antineoplastic Agents |