Stomach NeoplasmsFocusNCT01364376
S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma
A study testing S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium in people with Stomach Neoplasms, run by Zhejiang University at 8 sites in China.
Trial summary
This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer. Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 583 participants
- Where
- 8 sitesChina
- Study dates
- Jun 2011to Aug 2016
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa
- Ambulatory males or females, aged 18-80 years old
- ECOG score 0-2
- Given informed consent
- Life expectancy more than 3 months
- Measurable lesion
- Normal cardiac, hepatic, renal, and bone marrow function(WBC:3.5×10^9/l~12×10^9/l;PLT:>100×109/l;Bil:<1.5 fold of upper limit value; ALT/AST:<2.5 fold of upper limit value;Ccr:>80ml/min;Cr:1.5mg/dl)
Who cannot join
- Prior stomach surgery
- Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor
- History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis)
- Severe bleeding
- Bowel obstruction, ileus or complete pyloric obstruction
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- Serious uncontrolled concomitant disease
- History of myocardial infarction in 6 months
- Woman with on-going pregnancy or breast-feeding, or contemplating pregnancy
- Systemic treatment with corticosteroid
- Patients judged inappropriate for the trial by the physicians
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
The First Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang
The Second Affiliated Hospital of Medical School of Zhejiang University
Hangzhou, Zhejiang
Jiaxing First Hospital
Jiaxing, Zhejiang
Qilu Hospital of Shandong University
Jinan, Shandong
Shandong Provincial Hospital
Jinan, Shandong
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang
The second affiliated hospital of Wenzhou medical college
Wenzhou, Zhejiang
About this study
Official title: S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma: a Multi-center, Open-labeled, Randomized Controlled Trial
This is a randomized multicenter controlled study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer.
Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric cancer.
- Conditions
- Stomach Neoplasms
- Being tested
- S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium
- Keywords
- Gastric Cancer
- 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-1; Oxaliplatin; 5-Fu; Leucovorin CalciumDrug
FOLFOX:
oxaliplatin 130mg/m2 on day 1, CF 400mg/m2 on day 1, 5-Fu 400mg/m2 on day 1; 5-FU 2400 mg/m2 46hr civ regimen repeated every 3 weeks Pre-operative chemotherapy: 2-4 cycles and peri-operative chemotherapy consist of 6 cycles
SOX:
oxaliplatin 130mg/m2 on day 1, S-1 for 14 days regimen repeated every 3 weeks Pre-chemotherapy: 2-4 cycles, totally 6 cycles of perioperative chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| FOLFOX | Active comparator | Not described Receives: Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium |
| SOX | Experimental | Not described Receives: Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 3-year
Secondary outcomes (4)
progression-free survival(PFS)
Measured: 3-year
clinical response
Measured: 6 or 12 weeks
pathological response
Measured: within 10 days after surgery
Number of Participants with grade 3/4 adverse Events
Measured: 6 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2016
- Study completionAug 2016
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 Stomach NeoplasmsStudies of the same condition, open and under way.
- More trials run by Zhejiang 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiren Yu, Zhejiang University
- Investigators
- Jiren Yu, Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364376
- Sponsor's protocol ID
- ZYYY-GC1105
- Acronym
- Focus
- Status last verified
- Aug 2016
- First submitted
- 19 May 2011
- Last updated
- 23 Aug 2016
- Results posted
- No
Publications
Yu J, Gao Y, Chen L, Wu D, Shen Q, Zhao Z, Liu W, Yang H, Zhang Q, Wang X, Hu P, Zheng Z, Wang X, Liu H, Xu Z, Yan Z, Wu Y, Jin M, Zhang Q, Liu X, Zhu K, Shou C. Effect of S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Plus Oxaliplatin as Perioperative Chemotherapy for Locally Advanced, Resectable Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220426. doi: 10.1001/jamanetworkopen.2022.0426.
PubMed 35226081
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Calcium Plus Oxaliplatin as Perioperative Chemotherapy for Advanced Gastric Carcinoma: a Multi-center, Open-labeled, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01364376
- Acronym / sponsor ID
- Focus / ZYYY-GC1105
- Conditions
- Stomach Neoplasms
- Keywords
- Gastric Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Jun 2011 (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 study of oxaliplatin, leucovorin calcium , plus 5-fluorouracil (FOLFOX) compared with S-1 plus oxaliplatin (SOX) as perioperative chemotherapy for advanced gastric cancer.
Hypothesis: SOX is not inferior to FOLFOX as perioperative chemotherapy for advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FOLFOX | Active comparator | Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium |
| SOX | Experimental | Drug: S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed gastric adenocarcinoma,diagnosed as locally advanced gastric cancer and primary tumor invades or penetrates serosa
- Ambulatory males or females, aged 18-80 years old
- ECOG score 0-2
- Given informed consent
- Life expectancy more than 3 months
Key exclusion criteria (11 listed)
- Prior stomach surgery
- Previous cytotoxic chemotherapy, radiotherapy, target therapy or immunotherapy for any tumor
- History of another malignancy except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix
- distant metastasis(such as No.16 and No.13 lymphnode,liver, lung,brain,bones or peritoneal metastasis)
- Severe bleeding
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-1; Oxaliplatin; 5-Fu; Leucovorin CalciumFOLFOX: oxaliplatin 130mg/m2 on day 1, CF 400mg/m2 on day 1, 5-Fu 400mg/m2 on day 1; 5-FU 2400 mg/m2 46hr civ regimen repeated every 3 weeks Pre-operative chemotherapy: 2-4 cycles and peri-operative chemotherapy consist of 6 cycles SOX: oxaliplatin 130mg/m2 on day 1, S-1 for 14 days regimen repeated every 3 weeks Pre-chemotherapy: 2-4 cycles, totally 6 cycles of perioperative chemotherapy | Drug | FOLFOX, SOX |
Primary outcome
overall survival
Time frame: 3-year
4 secondary outcomes
progression-free survival(PFS)
Time frame: 3-year
clinical response
Time frame: 6 or 12 weeks
pathological response
Time frame: within 10 days after surgery
Number of Participants with grade 3/4 adverse Events
Time frame: 6 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 Aug 2016.
- Derived from this study: PubMed 35226081Yu J, Gao Y, Chen L, Wu D, Shen Q, Zhao Z, Liu W, Yang H, Zhang Q, Wang X, Hu P, Zheng Z, Wang X, Liu H, Xu Z, Yan Z, Wu Y, Jin M, Zhang Q, Liu X, Zhu K, Shou C. Effect of S-1 Plus Oxaliplatin Compared With Fluorouracil, Leucovorin Plus Oxaliplatin as Perioperative Chemotherapy for Locally Advanced, Resectable Gastric Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e220426. doi: 10.1001/jamanetworkopen.2022.0426.
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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.
Jiren Yu principal investigator
First Affiliated Hospital of Zhejiang University
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium in people with Stomach Neoplasms, run by Zhejiang University at 8 sites 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 7 inclusion and 11 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 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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.
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: 3-year). 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 NCT01364376, 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 23 Aug 2016.