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

Last updated: January 17, 2021
Sponsor: Chinese PLA General Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT04483076
RESONANCE-II
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Non-bedridden, aged 18 to 70 years old;
  2. Eastern Cooperative Oncology Group (ECOG) score is 0 to 1;
  3. Histologically confirmed gastric adenocarcinoma;
  4. Stage III (American Joint Committee on Cancer (AJCC) TNM staging system 8th edition)gastric cancer confirmed by enhanced computer tomography (enhanced CT) andlaparoscopic exploration (endoscopic ultrasonography (EUS) and magnetic resonanceimaging (MRI) if necessary);
  5. The research center and the surgeon have the ability to complete standard D2 radicalgastrectomy, and the gastrectomy can be tolerated by the patient;
  6. Laboratory test criteria: peripheral blood hemoglobin (Hb) ≥ 90 g/L, neutrophilabsolute 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;
  7. Patients with heart disease, the echocardiogram showed that the left ventricularejection fraction ≥ 50%, the electrocardiogram (ECG) is basically normal within 4weeks before operation and without no obvious symptoms are acceptable;
  8. There is no serious underlying disease that could lead to an expected life expectancy < 5 years;
  9. Willing to sign the inform consent for participation and publication of results.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women;
  2. Positive pregnancy test for women in childbearing age. Menopausal women withoutmenstruation for at least 12 months can be regarded as women with no possibility ofgetting pregnant;
  3. Refuse to birth control during the study;
  4. Received any chemotherapy, radiotherapy or immunotherapy before;
  5. History of other malignant diseases in the last five years (except for cervicalcarcinoma in situ);
  6. History of uncontrolled central nervous system diseases, which could influence thecompliance;
  7. History of severe liver diseases, renal diseases or respiratory diseases; Uncontrolleddiabetes and hypertension; Clinically severe heart disease, such as congestive heartfailure, symptomatic coronary heart disease, uncontrolled arrhythmia, or a history ofmyocardial infarction in the last six months;
  8. History of dysphagia, complete or partial gastrointestinal obstruction, activegastrointestinal bleeding and gastrointestinal perforation;
  9. On steroid treatment after organ transplant;
  10. With uncontrolled severe infections;
  11. Known dihydropyrimidine dehydrogenase deficiency (DPD);
  12. Anaphylaxis to any research drug ingredient;
  13. Known peripheral neuropathy (> NCI-CTC AE 1). Patients with only disappearance of deeptendon reflex need not to be excluded.

Study Design

Total Participants: 524
Study Start date:
January 13, 2021
Estimated Completion Date:
December 31, 2028

Study 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.

Connect with a study center

  • Chinese PLA General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

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