Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer

  • STATUS
    Recruiting
  • End date
    Dec 3, 2028
  • participants needed
    524
  • sponsor
    Chinese PLA General Hospital
Updated on 3 February 2021

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 three cycles of SOX. Then, tumor response evaluation will be carried out. Those who achieve stable disease or progressive disease will be excluded. Patients achieving complete response or partial response will be enrolled and assigned into either group A for another three cycles of SOX (six cycles in total) followed by D2 surgery and group B for D2 surgery (three cycles in total). The primary endpoint is the rate of pathological complete response and the secondary endpoints are R0 resection rate, three-year disease-free survival, five-year overall survival and safety.

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 for patients with locally advanced gastric cancer. All patients with eligibility will be registered, pre-enrolled and receive three cycles of SOX. Then, tumor response evaluation will be carried out according to the Response Evaluation Criteria for Solid Tumors (RECIST) 1.1. Those who achieve stable disease (SD) or progressive disease (PD)will be excluded. Patients achieving complete response (CR) or partial response (PR) will be enrolled and assigned into either group A (six cycles of neoadjuvant chemotherapy with SOX) for another three cycles of SOX followed by D2 surgery and group B (three cycles of neoadjuvant chemotherapy with SOX) for D2 surgery. The primary endpoint is the rate of pathological complete response (pCR%) and the secondary endpoints are R0 resection rate, three-year disease-free survival (3-y DFS), five-year overall survival (5-y OS) and safety.

Details
Condition Gastropathy, Stomach Discomfort, Gastric Cancer, Gastric Cancer, Stomach Cancer, Stomach Discomfort, Chemotherapy Effect, Gastric Carcinoma, Stomach Cancer, gastric cancers
Treatment Gastrectomy, Chemotherapy drug, Laparoscopic exploration
Clinical Study IdentifierNCT04483076
SponsorChinese PLA General Hospital
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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 3109 /L, platelet count (PLT) 100109 /L, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) 2.5 times the upper limit of normal (ULN), total bilirubin 1.5ULN, serum creatinine (SCr) 1.5ULN, 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 Criteria

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
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