- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04483076
Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer (RESONANCE-II)
January 17, 2021 updated by: Lin Chen, Chinese PLA General Hospital
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 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.
Study Type
Interventional
Enrollment (Anticipated)
524
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xinxin Wang, MD
- Phone Number: +8613811858199
- Email: 301wxx@sina.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Xinxin Wang, Dr.
- Phone Number: +8613811858199
- Email: 301wxx@sina.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 ≥ 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 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
Patients will be pre-enrolled and receive three cycles of SOX.
After randomization, patients in Arm A will receive three more cycles of SOX (six cycles of neoadjuvant chemotherapy with SOX in total) followed by D2 gastrectomy.
|
The preoperative SOX chemotherapy consists of three-week cycles of intravenously administered oxaliplatin 130 mg/m2 on day 1 and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14.
The dose of S-1 depends on body surface area (BSA): 40mg BID for BSA < 1.25 m2; 50mg BID for 1.25 m2 < BSA <1.5 m2; 60mg BID for BSA > 1.5 m2.
Day 15 to day 21 is the rest period.
Surgery is planned 3-4 weeks after the last cycle of chemotherapy.
A standard D2 radical laparoscopic gastrectomy is recommended.
The extent of gastric resection and lymphadenectomy were performed as per the treatment guidelines.
Reconstruction after gastrectomy was decided by the surgeon.
All operations are performed by well trained and experienced surgical team to guarantee the quality of surgery, including harvesting more than 16 lymph nodes.
Laparoscopic exploration is to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum according to the standard acquirements reported before.
Patients with any patterns of distant metastases, suggestive of distant metastasis (M1), will be excluded from the trial.
|
Active Comparator: Arm B
Patients will be pre-enrolled and receive three cycles of SOX.
After randomization, patients in Arm B will receive D2 gastrectomy (three cycles of neoadjuvant chemotherapy with SOX in total).
|
The preoperative SOX chemotherapy consists of three-week cycles of intravenously administered oxaliplatin 130 mg/m2 on day 1 and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14.
The dose of S-1 depends on body surface area (BSA): 40mg BID for BSA < 1.25 m2; 50mg BID for 1.25 m2 < BSA <1.5 m2; 60mg BID for BSA > 1.5 m2.
Day 15 to day 21 is the rest period.
Surgery is planned 3-4 weeks after the last cycle of chemotherapy.
A standard D2 radical laparoscopic gastrectomy is recommended.
The extent of gastric resection and lymphadenectomy were performed as per the treatment guidelines.
Reconstruction after gastrectomy was decided by the surgeon.
All operations are performed by well trained and experienced surgical team to guarantee the quality of surgery, including harvesting more than 16 lymph nodes.
Laparoscopic exploration is to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum according to the standard acquirements reported before.
Patients with any patterns of distant metastases, suggestive of distant metastasis (M1), will be excluded from the trial.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pCR rate
Time Frame: Postoperative, 2 years
|
The pCR rate is defined as the rate of patients achieving pCR.
|
Postoperative, 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
R0 resection rate
Time Frame: Postoperative, 2 years
|
The R0 resection rate is defined as the rate of R0 resection.
|
Postoperative, 2 years
|
Three-year disease-free survival
Time Frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 70 months
|
The DFS is defined as the period from the time of surgery to recurrence or death.
|
From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 70 months
|
Five-year overall survival
Time Frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 90 months
|
The OS is defined as the period from the time of surgery to death or last follow-up.
|
From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 90 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2021
Primary Completion (Anticipated)
December 1, 2022
Study Completion (Anticipated)
December 1, 2028
Study Registration Dates
First Submitted
July 19, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 23, 2020
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 17, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RESONANCE-II
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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