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NCT04483076RecruitingPhase 3

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

A Prospective, Multicenter, Randomized, Controlled Phase III Study Evaluating Different Cycles of Oxaliplatin Combined With S-1 (SOX) as Neoadjuvant Chemotherapy for Patients With Locally Advanced Gastric Cancer: RESONANCE-II Trial

Source: ClinicalTrials.gov · Last updated 20 Jan 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
524 (estimated)
First submitted
19 Jul 2020
Start date
13 Jan 2021
Primary completion date
Dec 2022
Lead sponsor
Chinese PLA General Hospital
NCT number
NCT04483076

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 524
  • From 13 Jan 2021 to the primary completion date, Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Received any chemotherapy, radiotherapy or immunotherapy before;
  • On steroid treatment after organ transplant;
  • Anaphylaxis to any research drug ingredient;

Other illness

  • 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;
  • With uncontrolled severe infections;

Age

  • 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;

Other

  • Pregnant or lactating women;
  • Refuse to birth control during the study;
  • Known dihydropyrimidine dehydrogenase deficiency (DPD);
  • Known peripheral neuropathy (\> NCI-CTC AE 1). Patients with only disappearance of deep tendon reflex need not to be excluded.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Chinese PLA General Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.