Gastric AdenocarcinomaPhase 3RESONANCENCT01583361
SOX Regimen as Neoadjuvant Chemotherapy for AJCC Stage II-III Gastric Cancer
A Phase 3 study testing Oxaliplatin+S-1 and Adjuvant Oxaliplatin/S-1（SOX） in people with Gastric Adenocarcinoma, run by Lin Chen at 1 site in China.
Trial summary
This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Oxaliplatin+S-1 and Adjuvant Oxaliplatin/S-1（SOX）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 772 participants
- Where
- 1 siteChina
- Study dates
- Mar 2012to Jan 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed gastric adenocarcinoma
- Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled
- All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stage classification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients can be enrolled
- planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- KPS > 60; ECOG performance status 0-2
- Life expectancy > 6 months
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- Age: 20 to 75 years
- No other severe disease and life expectancy less than five years
- 7 days before enrolled, baseline data should be finished including:
- Granulocyte count ≥ 1.5×109/L;
- platelet count ≥ 100×109/L;
- Hemoglobin ≥ 90g/L;
- hepatic < 1.5×ULN;
- total bilirubin ≤ 1.0×ULN;
- creatinine < 1.5×ULN;
- PT-INR/PTT < 1.7× ULN
- Disease had to be measurable by the Response Evaluation Criteria in Solid Tumors (RECIST1.1) criteria
- Written informed consent and able to comply with the protocol
Who cannot join
- Patient cannot undergo surgery or chemotherapy because of other severe disease
- Be allergic to chemotherapy drugs
- Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
- Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
- Within the last 5 years in patients with a history of other malignant diseases
- Pregnant or breast-feeding women
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- Severe heart disease like symptoms of coronary heart disease, New York Heart Association (NYHA) grade II or worse congestive heart failure or cardiac arrhythmia having medications or myocardial infarction within the last 12 months
- Patients with upper gastrointestinal obstruction or absorption anomaly; patient in obstruction of the Helicobacter pylori failure like effect S-1 to take and absorb
- Patients with a history of peripheral nerve disease
- Patients who get organ transplant
- lack of dihydropyrimidine dehydrogenase (DPD)
- Infection or other disease failure to control
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Tao Li, MD,PhD, 0086-10-66938328, litbj301@sina.com
About this study
Official title: Phase III, Randomized, Multicenter, Controlled Evaluation of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients
This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.
The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Oxaliplatin+S-1, Adjuvant Oxaliplatin/S-1（SOX）
- Keywords
- two arms, D2 lymphadenectomy, chemotherapy before and after surgery, disease free survival
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin+S-1Drug
Also called Oxaliplatin(Sanofi-aventis), S-1(Taiho)
S-1: 40~60mg bid，po, d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1
Adjuvant Oxaliplatin/S-1（SOX）Drug
Also called Oxaliplatin(Sanofi-aventis), S-1(Taiho)
S-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)
| Study group | Role | What they receive |
|---|---|---|
| Arm A:Neoadjuvant sox | Experimental | Patients in arm a will receive (N=2-4) cycles of neoadjuvant SOX first, and then standard gastrectomy with D2 lymphadenectomy, and (8-N) cycles of adjuvant SOX adjuvant chemotherapy. Receives: Drug: Oxaliplatin+S-1 |
| Arm B:Adjuvant SOX | Active comparator | Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later. Receives: Drug: Adjuvant Oxaliplatin/S-1（SOX） |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
SOX regimen as Neoadjuvant chemotherapy for AJCC II-III gastric cancer patients is superior than postoperative SOX after D2 surgery.Disease free survival is defined as time of surgery to recurrence or death.
Measured: three years
Secondary outcomes (3)
response rate
For neoadjuvant chemotherapy patients,response rate will be evaluated according to RECIST 1.1 criteria after at least 2 cycles of SOX chemotherapy.CT scan is required to every patient.
Measured: 3 months
overall survival
Neoadjuvant chemotherapy of SOX is superior than postoperative SOX after D2 dissection in AJCC II-III gastric cancer patients.Overall survival is defined as the time of randomization to death.
Measured: five years
safety
Number of participants with adverse events related to SOX chemotherapy.All adverse events are from CTCAE 4.0 criteria.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2012 (estimated)
- Study startMar 2012
- Primary completionSep 2014 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- 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
- 772 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lin Chen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lin Chen, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01583361
- Sponsor's protocol ID
- LCHEN-PLAGH
- Acronym
- RESONANCE
- Status last verified
- Apr 2012
- First submitted
- 4 Apr 2012
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang X, Lu C, Wei B, Li S, Li Z, Xue Y, Ye Y, Zhang Z, Sun Y, Liang H, Li K, Zhu L, Zheng Z, Zhou Y, He Y, Li F, Wang X, Liang P, Huang H, Li G, Shen X, Ji J, Tang Y, Xu Z, Chen L; RESONANCE study group. Perioperative versus adjuvant S-1 plus oxaliplatin chemotherapy for stage II/III resectable gastric cancer (RESONANCE): a randomized, open-label, phase 3 trial. J Hematol Oncol. 2024 Apr 8;17(1):17. doi: 10.1186/s13045-024-01536-7.
PubMed 38589926
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Randomized, Multicenter, Controlled Evaluation of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT01583361
- Acronym / sponsor ID
- RESONANCE / LCHEN-PLAGH
- Conditions
- Gastric Adenocarcinoma
- Keywords
- two arms, D2 lymphadenectomy, chemotherapy before and after surgery, disease free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 772 participants (estimated)
- Lead sponsor
- Lin ChenUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 24 Apr 2012 (estimated)
- 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.
This is a randomized, multicenter, controlled trial to prove efficacy of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Advanced Gastric Cancer Patients who undergo D2 gastrectomy.
The primary endpoint is three-year free disease and the second primary includes five-year overall survival, safety and R0 resection rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A:Neoadjuvant sox | Experimental | Drug: Oxaliplatin+S-1Patients in arm a will receive (N=2-4) cycles of neoadjuvant SOX first, and then standard gastrectomy with D2 lymphadenectomy, and (8-N) cycles of adjuvant SOX adjuvant chemotherapy. |
| Arm B:Adjuvant SOX | Active comparator | Drug: Adjuvant Oxaliplatin/S-1（SOX）Patients in arm B will receive standard gastrectomy with D2 Lymphadenectomy first, and 8 cycles of adjuvant SOX later. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed gastric adenocarcinoma
- Gastroesophageal junction tumour type II or III(NCCN 2009) can be enrolled
- All patients must undergo EUS,CT(or PET-CT) and laparoscopy to evaluate tumor stage classification (TNM), and only stage II or III (AJCC 7th) gastric cancer patients can be enrolled
- planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- KPS > 60; ECOG performance status 0-2
Key exclusion criteria (12 listed)
- Patient cannot undergo surgery or chemotherapy because of other severe disease
- Be allergic to chemotherapy drugs
- Patients receiving any chemotherapy or drugs involved in this trial in four weeks before enrolled
- Patients received cytotoxic chemotherapy, targeted therapy, immunotherapy or radiotherapy for gastric cancer
- Within the last 5 years in patients with a history of other malignant diseases
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 |
|---|---|---|
| Oxaliplatin+S-1Also: Oxaliplatin(Sanofi-aventis), S-1(Taiho)S-1: 40~60mg bid，po, d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1 | Drug | Arm A:Neoadjuvant sox |
| Adjuvant Oxaliplatin/S-1（SOX）Also: Oxaliplatin(Sanofi-aventis), S-1(Taiho)S-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months) | Drug | Arm B:Adjuvant SOX |
Primary outcome
disease free survival
Time frame: three years
SOX regimen as Neoadjuvant chemotherapy for AJCC II-III gastric cancer patients is superior than postoperative SOX after D2 surgery.Disease free survival is defined as time of surgery to recurrence or death.
3 secondary outcomes
response rate
Time frame: 3 months
overall survival
Time frame: five years
safety
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- Derived from this study: PubMed 38589926Wang X, Lu C, Wei B, Li S, Li Z, Xue Y, Ye Y, Zhang Z, Sun Y, Liang H, Li K, Zhu L, Zheng Z, Zhou Y, He Y, Li F, Wang X, Liang P, Huang H, Li G, Shen X, Ji J, Tang Y, Xu Z, Chen L; RESONANCE study group. Perioperative versus adjuvant S-1 plus oxaliplatin chemotherapy for stage II/III resectable gastric cancer (RESONANCE): a randomized, open-label, phase 3 trial. J Hematol Oncol. 2024 Apr 8;17(1):17. doi: 10.1186/s13045-024-01536-7.
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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. This study is not recruiting at the moment.
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 Oxaliplatin+S-1 and Adjuvant Oxaliplatin/S-1（SOX） in people with Gastric Adenocarcinoma, run by Lin Chen 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 18 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 24 Apr 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Li, MD,PhD (86-10-66938328, litbj301@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease free survival (time frame: three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01583361, which also lists 1 linked publication.
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 24 Apr 2012.