Gastric CancerPhase 3NCT01824459
S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment of Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma Patients
A Phase 3 study testing S-1, Oxaliplatin and Cisplatin in people with Gastric Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1, Oxaliplatin and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 576 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to 1 Dec 2018
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-type gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- 18 years old to 75 years old, able to conduct oral administration.
- Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST 1.1)
- No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant chemotherapy , if applicable, more than 12 months.
- ECOG systemic status score of 0 to 2.
- normal organ function, that meet the following criteria:
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- ALT and AST(≤2.5 times ULN (≤5 times ULN in patients with liver metastases)
- ALP ≤ 2 times ULN ; (for patients with liver metastases can be no limit to the ALP).
- Total bilirubin ≤ 1 times ULN.
- Absolute neutrophil count ≥ 2.0 × 10^9 / L.
- Platelet count ≥ 100 × 10^9 / L.
- Hemoglobin ≥ 80g / L.
- Creatinine ≤ 1.25 times ULN.
- The estimated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula).
- Signed informed consent, treatment, follow-up and inspection in accordance with the study protocol.
- Life expectancy greater than 3 months.
- At least 3 weeks after major surgery.
Who cannot join
- Previous adjuvant or neoadjuvant chemotherapy within the prescribed time
- the investigator determines that the patient is not suitable for participation in this study, and specifically includes (but is not limited to):
- The past five years there have been other malignancies, but after appropriate treatment of cervical carcinoma in situ and non-melanoma skin cancer.
- brain metastases or leptomeningeal metastasis.
- myocardial infarction (within the past six months), severe unstable angina, congestive heart failure.
- Serious complications (including paralytic ileus, intestinal obstruction, interstitial pneumonia, lung fibrosis, beyond the control of diabetes, renal insufficiency and cirrhosis of the liver, etc.).
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- Chronic nausea, vomiting, or diarrhea (per day greater than or equal to 4 times or watery stools).
- Gastrointestinal bleeding, and need for frequent blood transfusions.
- human immunodeficiency virus (HIV) carrier or suffering from AIDS (AIDS).
- Suffering from a mental illness.
- neuropathy severity ≥grade 2 .
- Infectious disease or inflammation, body temperature ≥ 38 ℃.
- Cisplatin, oxaliplatin, or S-1 allergy.
- Pregnancy or breast-feeding women.
- refused to take appropriate contraceptive measures (including male patients).
- Under experimental drug within 4 weeks.
- Under other anti-cancer treatment.
- HER2 IHC(3+) or IHC(2+) /FISH(+)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open, Multi-center, Phase III Study of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients
The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.
Read the detailed description
The primary endpoint is Overall survival time (OS).Secondary endpoints are overall response rate (ORR), time to treatment failure (TTF),progression free survival (PFS)and the adverse reactions(AE) of the two groups .
Study design:
This is a prospective randomized control study.
Sample size:
Sample size considerations were based on the survival end point. The improvement in median survival from 10 months in the S-1+cisplatin arm to 13 months in the S-1+oxaliplatin arm was considered clinically relevant in this patient population. A total of 576 patients were required for a two-tailed log-rank test at the 5% significance and at least 80% power. The planned enrolled time was 48 months and 1 year of follow up, and a drop-out rate of 5%.
- Conditions
- Gastric Cancer
- Being tested
- S-1, Oxaliplatin, Cisplatin
- Keywords
- Non-intestinal type gastric cancer, Advance Gastric Cancer, Recurrent Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, SOX, S-1+Oxaliplatin, OS,, ORR,, PFS,, TTF,, safety
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
S-1：40~60mg bid，d1~14 q3W
OxaliplatinDrug
oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W
CisplatinDrug
cisplatin：60mg/m2，iv drip ，d1,q3W
| Study group | Role | What they receive |
|---|---|---|
| S-1 + cisplatin(SP) | Active comparator | S-1：40~60mg bid，d1~14 q3W cisplatin：60mg/m2，iv drip ，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops. Receives: Drug: S-1; Drug: Cisplatin |
| S-1+Oxaliplatin（SOX） | Experimental | S-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops. Receives: Drug: S-1; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost
Measured: 1-1.5 year
Secondary outcomes (4)
Objective response rate
The primary endpoint is objective response rate,which equals CR+PR.
Measured: 1 year
time to treatment failure (TTF)
The duration is from the randomized time to treatment termination due to any reason. The reasons may include disease progression, treatment toxicity, patient selection or death.
Measured: 6 months
progression-free survival (PFS)
The duration is from the randomized time to disease progression or death due to any reason.
Measured: 6 months
Adverse events (AE)
Measured: 1-1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startApr 2013
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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 Sun Yat-sen UniversityThe 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
- 576 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- ruihua xu, Professor, Principal investigator, SunYat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824459
- Sponsor's protocol ID
- SOX-DGCA
- Status last verified
- Jan 2019
- First submitted
- 1 Apr 2013
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Multi-center, Phase III Study of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Type Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients
- ClinicalTrials.gov ID
- NCT01824459
- Acronym / sponsor ID
- SOX-DGCA
- Conditions
- Gastric Cancer
- Keywords
- Non-intestinal type gastric cancer, Advance Gastric Cancer, Recurrent Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, SOX, S-1+Oxaliplatin, OS,, ORR,, PFS,
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 576 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- Apr 2013
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 4 Apr 2013 (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.
The purpose of this study is to evaluate the effectiveness and safety of S-1+Oxaliplatin vs.S-1+Cisplatin First-line Treatment in Advanced or Recurrent Non-intestinal Gastric Adenocarcinoma or Gastroesophageal Junction Adenocarcinoma Patients.
Detailed description
The primary endpoint is Overall survival time (OS).Secondary endpoints are overall response rate (ORR), time to treatment failure (TTF),progression free survival (PFS)and the adverse reactions(AE) of the two groups .
Study design:
This is a prospective randomized control study.
Sample size:
Sample size considerations were based on the survival end point. The improvement in median survival from 10 months in the S-1+cisplatin arm to 13 months in the S-1+oxaliplatin arm was considered clinically relevant in this patient population. A total of 576 patients were required for a two-tailed log-rank test at the 5% significance and at least 80% power. The planned enrolled time was 48 months and 1 year of follow up, and a drop-out rate of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1 + cisplatin(SP) | Active comparator | Drug: S-1, Drug: CisplatinS-1：40~60mg bid，d1~14 q3W cisplatin：60mg/m2，iv drip ，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops. |
| S-1+Oxaliplatin（SOX） | Experimental | Drug: S-1, Drug: OxaliplatinS-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W Number of Cycles: until progression or unacceptable toxicity develops. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- histologically confirmed unresectable advanced or recurrent diffuse-type or mixed-type gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
- 18 years old to 75 years old, able to conduct oral administration.
- Measurable disease or non-measurable but evaluable disease, according to the Response Evaluation Criteria in Solid Tumours(RECIST 1.1)
- No palliative chemotherapy and radiotherapy. Previous adjuvant or neoadjuvant chemotherapy , if applicable, more than 12 months.
- ECOG systemic status score of 0 to 2.
Key exclusion criteria (18 listed)
- Previous adjuvant or neoadjuvant chemotherapy within the prescribed time
- the investigator determines that the patient is not suitable for participation in this study, and specifically includes (but is not limited to):
- Cisplatin, oxaliplatin, or S-1 allergy.
- Pregnancy or breast-feeding women.
- refused to take appropriate contraceptive measures (including male patients).
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 |
|---|---|---|
| S-1S-1：40~60mg bid，d1~14 q3W | Drug | S-1 + cisplatin(SP), S-1+Oxaliplatin（SOX） |
| Oxaliplatinoxaliplatin：130mg/m2，iv drip for 2h，d1,q3W | Drug | S-1+Oxaliplatin（SOX） |
| Cisplatincisplatin：60mg/m2，iv drip ，d1,q3W | Drug | S-1 + cisplatin(SP) |
Primary outcome
Overall Survival
Time frame: 1-1.5 year
OS means that from the first dose of treatment drug to death or lost, the follow-up visit will be performed every 12 weeks till death or lost
4 secondary outcomes
Objective response rate
Time frame: 1 year
time to treatment failure (TTF)
Time frame: 6 months
progression-free survival (PFS)
Time frame: 6 months
Adverse events (AE)
Time frame: 1-1.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
ruihua xu, Professor principal investigator
SunYat-sen University Cancer Center
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 S-1, Oxaliplatin and Cisplatin in people with Gastric Cancer, run by Sun Yat-sen University 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 17 inclusion and 18 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: finished, as of the sponsor's last update on 23 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: 1-1.5 year). 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 23 Jan 2019.