Gastric CancerPhase 2NCT01090505
Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
A Phase 2 study testing Drug: S-1 and oxaliplatin in people with Gastric Cancer, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Drug: S-1 and oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- Nov 2009to Dec 2015
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
- Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- Age:20 to 75
- Performance status:ECOG 0-2
- Life expectancy:Not specified
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- Hematopoietic:WBC 4,000-12,000/mm^3；Granulocyte count ≥ 2,000/mm^3；Platelet count ≥ 100,000/mm^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL
- Adequate organ function
- Able to swallow oral medication
- Written informed consent
Who cannot join
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- Pregnant or breast-feeding women
- Severe mental disease
- Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
- Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
- Myocardial infarction within six disease-free months
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China PLA General Hospital
Beijing, Beijing Municipality, 100853
Fu xing road 28#, 86-10-66938328
About this study
Official title: Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
- Conditions
- Gastric Cancer
- Being tested
- Drug: S-1 and oxaliplatin
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug: S-1 and oxaliplatinDrug
Also called S-1:Taiho, Oxaliplatin：sanofi-aventis
Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Drug:S-1:80mg/m2;oxaliplatin 130mg/m2 | Experimental | Drug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy Receives: Drug: Drug: S-1 and oxaliplatin |
| surgery | No intervention | Procedure/Surgery: Gastrectomy with D2 dissection Receives: Drug: Drug: S-1 and oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 5 years
Secondary outcomes (1)
response rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2015 (estimated)
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 Chinese PLA General HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090505
- Sponsor's protocol ID
- GC-ChinaPLAGH-2010
- Status last verified
- Nov 2009
- First submitted
- 16 Mar 2010
- Last updated
- 22 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
- ClinicalTrials.gov ID
- NCT01090505
- Acronym / sponsor ID
- GC-ChinaPLAGH-2010
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Mar 2010 (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 whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug:S-1:80mg/m2;oxaliplatin 130mg/m2 | Experimental | Drug: Drug: S-1 and oxaliplatinDrug: Neoadjuvant chemotherapy(S-1+Oxaliplatin) followed by D2 gastrectomy |
| surgery | No intervention | Drug: Drug: S-1 and oxaliplatinProcedure/Surgery: Gastrectomy with D2 dissection |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- DISEASE CHARACTERISTICS:
- Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
- Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
- Age:20 to 75
- Performance status:ECOG 0-2
Key exclusion criteria (6 listed)
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- Pregnant or breast-feeding women
- Severe mental disease
- Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
- Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
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 |
|---|---|---|
| Drug: S-1 and oxaliplatinAlso: S-1:Taiho, Oxaliplatin：sanofi-aventisDrug:S-1:80mg/m2;oxaliplatin 130mg/m2 | Drug | Drug:S-1:80mg/m2;oxaliplatin 130mg/m2, surgery |
Primary outcome
overall survival
Time frame: 5 years
1 secondary outcome
response rate
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2010.
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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 2 study testing Drug: S-1 and oxaliplatin in people with Gastric Cancer, run by Chinese PLA General Hospital 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 10 inclusion and 6 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 22 Mar 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact L Chen, MD (86-10-66938028, litbj301@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 5 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 22 Mar 2010.