Stomach NeoplasmsPhase 2NCT01531452
The Efficacy of Oxaliplatin Plus S-1 for Treatment of Gastric Cancer
A Phase 2 study testing Oxaliplatin and s1 in people with Stomach Neoplasms, run by Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- Oxaliplatin and s1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Jun 2011to Jun 2013
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
- Measurable lesion and/or non-measurable lesion defined by RECIST
- ECOG performance status ≦ 1
- Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
- Creatine ≦ upper normal limit (UNL)
- Total bilirubin ≦ 1.5 X UNL
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- AST, ALT and ALP ≦ 2.5 x UNL
- Subjects must be able to take orally
- No prior chemotherapy
- Life expectancy estimated than 3 months
- Written informed consent
Who cannot join
- Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
- Known brain metastases
- History of hypersensitivity to fluoropyrimidines, oxaliplatin
- Active double cancer
- Treatment with any investigational product during the last 4 weeks prior to study entry
- Symptomatic peripheral neuropathy ≧ garde 2. by NCI-CTCAE ver.3.0
- Any previous chemotherapy or radiotherapy for AGC
Trial locations and contacts
1 site in 1 country.
China1 site
cancer hospital & Institute,Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
The purpose of this study is to determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
Read the detailed description
There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.
- Conditions
- Stomach Neoplasms
- Being tested
- Oxaliplatin, s1
- Keywords
- Stomach Neoplasms, drug therapy, oxaliplatin, s1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxaliplatinDrug
Also called eloxatin
130mg/m2 d1,repeated q21d
s1Drug
Also called TS-1
80mg/m2/d, d1-14,repeated q21d
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | oxaliplatin+s1 Receives: Drug: Oxaliplatin; Drug: s1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
Measured: 2 years
Secondary outcomes (3)
Response Rate
From date of treatment was administered until the date of first documented response to treatment according to RECIST criteria,assessed every 2 cycles
Measured: 2 years
overall survival
From date of treatment was administered until the date of death from any cause,assessed every 3 months
Measured: 2 years
number of participants with adverse events
assessed from treatment was administered until 1 months after withdrawing from study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJun 2011
- Primary completionNov 2012
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach NeoplasmsStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 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
- Jinwan Wang, MD, Principal investigator, cancer hospital&institute,Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531452
- Sponsor's protocol ID
- CH-GI-016
- Status last verified
- Dec 2014
- First submitted
- 6 Feb 2012
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Phase II Study of Oxaliplatin Plus S-1 (SOX) as First-line Treatment for Patients With Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT01531452
- Acronym / sponsor ID
- CH-GI-016
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, drug therapy, oxaliplatin, s1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 13 Feb 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 determine the efficacy and safety of oxaliplatin and s1 as first-line treatment of advanced gastric cancer.
Detailed description
There was no evidence of standard chemotherapy for advanced gastric cancer (AGC) in China. Fluoropyrimidines and cisplatin have been widely used in a variety of combinations in the treatment of AGC. Capecitabine/cisplatin combination therapy showed an overall response rate (ORR) of 41- 55%, a median time to progression/progression free survival (TTP/PFS) of 5.6-6.3 months, and a median overall survival (OS) of 10.1-10.5 months. Though no studies have compared two oral fluoropyrimidines in combination with oxaliplatin, both S-1 and capecitabine appear to be comparable in terms of efficacy and safety. The investigators conducted a phase II trial of oxaliplatin combined with S-1 in the treatment of first-line AGC.
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: Oxaliplatin, Drug: s1oxaliplatin+s1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically proven in operable advanced gastric adenocarcinoma (including adenocarcinoma of the gastrooesophageal junction) or relapse gastric adenocarcinoma
- Measurable lesion and/or non-measurable lesion defined by RECIST
- ECOG performance status ≦ 1
- Hgb ≧ 8g/dL, WBC 4000-12000/mm3, platelets ≧ 100,000/mm3
- Creatine ≦ upper normal limit (UNL)
Key exclusion criteria (7 listed)
- Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
- Known brain metastases
- History of hypersensitivity to fluoropyrimidines, oxaliplatin
- Active double cancer
- Treatment with any investigational product during the last 4 weeks prior to study entry
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 |
|---|---|---|
| OxaliplatinAlso: eloxatin130mg/m2 d1,repeated q21d | Drug | treatment |
| s1Also: TS-180mg/m2/d, d1-14,repeated q21d | Drug | treatment |
Primary outcome
Progression Free Survival
Time frame: 2 years
from date of treatment was administered until the date of first documented progression or death from any cause whichever first, assessed every 6 weeks
3 secondary outcomes
Response Rate
Time frame: 2 years
overall survival
Time frame: 2 years
number of participants with adverse events
Time frame: 2 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 4 Dec 2014.
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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.
Jinwan Wang, MD principal investigator
cancer hospital&institute,Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oxaliplatin and s1 in people with Stomach Neoplasms, 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 11 inclusion and 7 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 4 Dec 2014. 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 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?
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?
Progression Free Survival (time frame: 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 4 Dec 2014.