Status:
RECRUITING
Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Gastric Cancer
Chemotherapy Effect
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which will enroll 524 patients in total. Patients with eligibility will be registered, pre-enrolled and receive...
Detailed Description
RESONANCE-II trial is a prospective, multicenter, randomized, controlled phase III study which was designed to evaluate the efficacy and safety of different cycles of SOX as neoadjuvant chemotherapy f...
Eligibility Criteria
Inclusion
- Non-bedridden, aged 18 to 70 years old;
- Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
- Histologically confirmed gastric adenocarcinoma;
- Stage III (American Joint Committee on Cancer (AJCC) TNM staging system 8th edition) gastric cancer confirmed by enhanced computer tomography (enhanced CT) and laparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonance imaging (MRI) if necessary);
- The research center and the surgeon have the ability to complete standard D2 radical gastrectomy, and the gastrectomy can be tolerated by the patient;
- Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophil absolute count ≥ 3×109 /L, platelet count (PLT) ≥ 100×109 /L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN), total bilirubin ≤ 1.5×ULN, serum creatinine (SCr) ≤ 1.5×ULN, and serum albumin (ALB) ≥ 30 g/L;
- Patients with heart disease, the echocardiogram showed that the left ventricular ejection fraction ≥ 50%, the electrocardiogram (ECG) is basically normal within 4 weeks before operation and without no obvious symptoms are acceptable;
- There is no serious underlying disease that could lead to an expected life expectancy \< 5 years;
- Willing to sign the inform consent for participation and publication of results.
Exclusion
- Pregnant or lactating women;
- Positive pregnancy test for women in childbearing age. Menopausal women without menstruation for at least 12 months can be regarded as women with no possibility of getting pregnant;
- Refuse to birth control during the study;
- Received any chemotherapy, radiotherapy or immunotherapy before;
- History of other malignant diseases in the last five years (except for cervical carcinoma in situ);
- History of uncontrolled central nervous system diseases, which could influence the compliance;
- History of severe liver diseases, renal diseases or respiratory diseases; Uncontrolled diabetes and hypertension; Clinically severe heart disease, such as congestive heart failure, symptomatic coronary heart disease, uncontrolled arrhythmia, or a history of myocardial infarction in the last six months;
- History of dysphagia, complete or partial gastrointestinal obstruction, active gastrointestinal bleeding and gastrointestinal perforation;
- On steroid treatment after organ transplant;
- With uncontrolled severe infections;
- Known dihydropyrimidine dehydrogenase deficiency (DPD);
- Anaphylaxis to any research drug ingredient;
- Known peripheral neuropathy (\> NCI-CTC AE 1). Patients with only disappearance of deep tendon reflex need not to be excluded.
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
524 Patients enrolled
Trial Details
Trial ID
NCT04483076
Start Date
January 13 2021
End Date
December 1 2028
Last Update
January 20 2021
Active Locations (1)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853