Gastric CancerPhase 3RESONANCE-IINCT04483076
Oxaliplatin Combined With S-1(SOX) Neoadjuvant Chemotherapy for Different Cycles in Patients With Gastric Cancer
A Phase 3 study testing Chemotherapy drug, Gastrectomy and Laparoscopic exploration in people with Gastric Cancer and Chemotherapy Effect, run by Chinese PLA General Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer, Chemotherapy Effect
- What is being tested?
- Chemotherapy drug, Gastrectomy and Laparoscopic exploration
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 524 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2021to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xinxin Wang, Dr., +8613811858199, 301wxx@sina.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Being tested
- Chemotherapy drug, Gastrectomy, Laparoscopic exploration
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chemotherapy drugDrug
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.
GastrectomyProcedure or surgery
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 explorationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | 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. Receives: Drug: Chemotherapy drug; Procedure: Gastrectomy; Procedure: Laparoscopic exploration |
| Arm B | Active comparator | 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). Receives: Drug: Chemotherapy drug; Procedure: Gastrectomy; Procedure: Laparoscopic exploration |
What is being measured
The primary outcome is the main question the study is designed to answer.
pCR rate
The pCR rate is defined as the rate of patients achieving pCR.
Measured: Postoperative, 2 years
Secondary outcomes (3)
R0 resection rate
The R0 resection rate is defined as the rate of R0 resection.
Measured: Postoperative, 2 years
Three-year disease-free survival
The DFS is defined as the period from the time of surgery to recurrence or death.
Measured: 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
The OS is defined as the period from the time of surgery to death or last follow-up.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2020
- Study start13 Jan 2021
- Primary completionDec 2022 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 524 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04483076
- Sponsor's protocol ID
- RESONANCE-II
- Acronym
- RESONANCE-II
- Status last verified
- Jan 2021
- First submitted
- 19 Jul 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04483076
- Acronym / sponsor ID
- RESONANCE-II / RESONANCE-II
- Conditions
- Gastric Cancer, Chemotherapy Effect
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 524 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 13 Jan 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 23 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Chemotherapy drug, Procedure: Gastrectomy, Procedure: Laparoscopic explorationPatients 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. |
| Arm B | Active comparator | Drug: Chemotherapy drug, Procedure: Gastrectomy, Procedure: Laparoscopic explorationPatients 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). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy drugThe 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. | Drug | Arm A, Arm B |
| GastrectomySurgery 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. | Procedure or surgery | Arm A, Arm B |
| Laparoscopic explorationLaparoscopic 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. | Procedure or surgery | Arm A, Arm B |
Primary outcome
pCR rate
Time frame: Postoperative, 2 years
The pCR rate is defined as the rate of patients achieving pCR.
3 secondary outcomes
R0 resection rate
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Chemotherapy drug, Gastrectomy and Laparoscopic exploration in people with Gastric Cancer and Chemotherapy Effect, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinxin Wang, MD (+8613811858199, 301wxx@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pCR rate (time frame: Postoperative, 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.