Gastric CancerPhase 1/2NCT01542294
SOX as Adjuvant Chemotherapy for Resectable Gastric Cancer
A Phase 1/2 study testing s1 and Oxaliplatin in people with Gastric Cancer, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- s1 and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Apr 2017
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20-70 years
- Histologically proven adenocarcinoma of the stomach
- Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery
- Stage II, III (AJCC 7th edition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- No prior chemotherapy or radiotherapy
- Adequate bone marrow, renal, and liver function
Who cannot join
- Any evidence of metastatic disease (including presence of tumor cells in the ascites).
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
- Pregnant or lactating women.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
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- Organ allografts requiring immunosuppressive therapy.
- Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency. Hypersensitivity to platinum compounds or any of the components of the study medications.
- Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before enter the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Medical Oncology,Cancer hospital and Institute,CAMS
Beijing, 100021
About this study
Official title: Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.
Read the detailed description
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
- Conditions
- Gastric Cancer
- Being tested
- s1, Oxaliplatin
- Keywords
- gastric cancer, S-1, oxaliplatin, adjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
s1Drug
Also called TS-1
60-90mg/m2/d P.O. day 1-14, repeated every 21 days
OxaliplatinDrug
Also called Eloxatin
130mg/m2 d1 repeated every 21 days
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | s1+oxaliplatin Receives: Drug: s1; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
chemotherapy complete rate
percentage of patients who completed eight cycles of chemotherapy
Measured: 6 months
Secondary outcomes (3)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
assessed from surgery until 1 months after withdrawing from study
Measured: 3 years
recurrence-free survival(RFS)
from the date of surgery until the occurrence of an event (relapse or death whichever came first)
Measured: 3 years
overall survival(OS)
from the date of surgery to any cause of death
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startJun 2011
- Primary completionSep 2014
- Study completionApr 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 CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Yang, Chinese Academy of Medical Sciences
- Investigators
- Lin Yang, MD, Principal investigator, Department of Medical Oncology,Cancer Hospital and Institute,CAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542294
- Sponsor's protocol ID
- CH-GI-020
- Status last verified
- Jun 2016
- First submitted
- 16 Oct 2011
- Last updated
- 14 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang G, Zhao J, Song Y, Zhang W, Sun Y, Zhou A, Huang J, Du F, Yang L. Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer. BMC Cancer. 2018 May 9;18(1):547. doi: 10.1186/s12885-018-4480-9.
PubMed 29743043
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Study of Oral S-1 Plus f Oxaliplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
- ClinicalTrials.gov ID
- NCT01542294
- Acronym / sponsor ID
- CH-GI-020
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, S-1, oxaliplatin, adjuvant chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Sep 2014 (actual)
- Study completion
- Apr 2017 (estimated)
- First posted
- 2 Mar 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.
The purpose of this study is to assess the safety and efficacy of S-1 plus oxaliplatin combination chemotherapy based on the adverse events and survival period by performing a phase I/II study of this combination in patients with D2 resection of gastric cancer.
Detailed description
This stage I/II study is designed to evaluate the appropriate dose of S-1 plus fixed-dose of oxaliplatin (SOX regimen) for Patients with D2 resection of gastric cancer and survival of SOX regimen for stage II-III patients(AJCC 7th). To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 3 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: s1, Drug: Oxaliplatins1+oxaliplatin |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 20-70 years
- Histologically proven adenocarcinoma of the stomach
- Curative D2 lymphadenectomy resection for gastric cancer, who can start chemotherapy be within 6 weeks after surgery
- Stage II, III (AJCC 7th edition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
Key exclusion criteria (10 listed)
- Any evidence of metastatic disease (including presence of tumor cells in the ascites).
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
- Pregnant or lactating women.
- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
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 |
|---|---|---|
| s1Also: TS-160-90mg/m2/d P.O. day 1-14, repeated every 21 days | Drug | treatment |
| OxaliplatinAlso: Eloxatin130mg/m2 d1 repeated every 21 days | Drug | treatment |
Primary outcome
chemotherapy complete rate
Time frame: 6 months
percentage of patients who completed eight cycles of chemotherapy
3 secondary outcomes
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 3 years
recurrence-free survival(RFS)
Time frame: 3 years
overall survival(OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2016.
- Derived from this study: PubMed 29743043Wang G, Zhao J, Song Y, Zhang W, Sun Y, Zhou A, Huang J, Du F, Yang L. Phase II study of adjuvant chemotherapy with S1 plus oxaliplatin for Chinese patients with gastric cancer. BMC Cancer. 2018 May 9;18(1):547. doi: 10.1186/s12885-018-4480-9.
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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.
Lin Yang, MD principal investigator
Department of Medical Oncology,Cancer Hospital and Institute,CAMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing s1 and Oxaliplatin in people with Gastric Cancer, run by Chinese Academy of Medical Sciences 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 7 inclusion and 10 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 14 Jun 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
chemotherapy complete rate (time frame: 6 months). 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 NCT01542294, 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 14 Jun 2016.