Stomach NeoplasmsPhase 2NCT00515190
Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
A Phase 2 study testing S-1,oxaliplatin in people with Stomach Neoplasms, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. 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?
- S-1,oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Aug 2010
- 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 or cytologically confirmed gastric adenocarcinoma with recurrent and/or metastatic disease
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or non-measurable evaluable
- No prior treatment for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; prior oxaliplatin is not allowed)
- Adequate major organ function including the following: Hematopoietic function: ANC >= 1,500/mm3, Platelet >= 100,000/mm3, Hepatic function: serum bilirubin =< 1.5 x ULN, AST/ALT levels =< 2.5 x ULN (=< 5 x ULN if liver metastases are present)Renal function: serum creatinine =< 1.5 x ULN
- Patients should sign a written informed consent before study entry
Who cannot join
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
- Patients with active (significant or uncontrolled) gastrointestinal bleeding
- Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0
- Prior and/or current history of peripheral neuropathy
- grade 1 NCI-CTCAE version 3.0
- Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
Show all 17Show fewer
- Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
- Other malignancy within the past 3 years except non-melanomatous skin cancer or carcinoma in situ of the cervix
- History of or current brain metastases
- Psychiatric disorder that would preclude compliance
- Females with a positive or no pregnancy test (within 7 days before treatment start) until childbearing potential can be otherwise excluded (postmenopausal i.e. amenorrheic for at least 2 years, hysterectomy or oophorectomy)
- Subjects with reproductive potential not willing to use an effective method of contraception
- Lactating women
- Known dihydropyrimidine dehydrogenase deficiency
- Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or warfarin et al.
- Major surgery within 4 weeks of start of study treatment, without complete recovery
- Radiotherapy within 4 weeks of start of study treatment; 2 weeks interval allowed if palliative radiotherapy was given to bone metastatic site and patient recovered from any acute toxicity
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center Korea
Goyang-si, Gyeonggi-do
Sook Ryun Park, M.D., +82-31-920-1609, sukryun73@ncc.re.kr
Se Youn Jang, M.S., +82-31-920-0667, jj96smc@naver.com
About this study
Official title: A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.
- Conditions
- Stomach Neoplasms
- Being tested
- S-1,oxaliplatin
- Keywords
- Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, oxaliplatin
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1,oxaliplatinDrug
Arm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal.
Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | (continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal. Receives: Drug: S-1,oxaliplatin |
| B | Active comparator | (intermittent arm): Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles. Receives: Drug: S-1,oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survial in the two treatment arms
Measured: During study period
Secondary outcomes (1)
Response rate, toxicity, duration of response, time to progression, Quality of life in the two treatment arms,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics, treatment efficacy and toxicity
Measured: During study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Investigators
- Sook Ryun Park, M.D., Principal investigator, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515190
- Sponsor's protocol ID
- NCCCTS-07-265
- Other IDs
- 82-31-920-1609
- Status last verified
- Dec 2007
- First submitted
- 10 Aug 2007
- Last updated
- 7 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Continuous or Intermittent S-1 Combined With Oxaliplatin in Recurrent or Metastatic Gastric Carcinoma
- ClinicalTrials.gov ID
- NCT00515190
- Acronym / sponsor ID
- NCCCTS-07-265
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, oxaliplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 198 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- Jul 2007
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 13 Aug 2007 (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.
Randomized phase II study designed to evaluate the efficacy and safety of continuous S-1 plus oxaliplatin versus intermittent S-1 plus oxaliplatin as first-line therapy in patients with recurrent and/or metastastic gastric carcinoma. Within 2 weeks of the end of induction chemotherapy of 6 cycles with S-1 plus oxalipatin, patients who don't experience progression will be randomized to the continuous S-1 plus oxaliplatin arm or the intermittent S-1 plus oxaliplatin arm in a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: S-1,oxaliplatin(continuous):S-1 plus oxalipatin will be continued until disease progression, unacceptable toxicity or consent withdrawal. |
| B | Active comparator | Drug: S-1,oxaliplatin(intermittent arm): Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed gastric adenocarcinoma with recurrent and/or metastatic disease
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) or non-measurable evaluable
- No prior treatment for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant therapy is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study; prior oxaliplatin is not allowed)
Key exclusion criteria (17 listed)
- Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome (e.g. patients with partial or total gastrectomy can enter the study, but not those with a jejunostomy probe), or inability to take oral medication
- Patients with active (significant or uncontrolled) gastrointestinal bleeding
- Residual relevant toxicity resulting from previous therapy (with the exception of alopecia) ≥ grade 2 NCI-CTCAE version 3.0
- Prior and/or current history of peripheral neuropathy
- Inadequate cardiovascular function:New York Heart Association class III or IV heart diseaseUnstable angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
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,oxaliplatinArm A (continuous arm): S-1 80mg/m2/d p.o. twice daily(q 12-h)on D1(evening)-D15(morning)plus oxaliplatin 130mg/m2 IV(in the vein)on D1 every 3 weeks, until disease progression, unacceptable toxicity, or consent withdrawal. Arm B (intermittent arm):Treatment will be stopped after the initial 6 cycles of S-1 plus oxaliplatin, and then S-1 plus oxaliplatin will be resumed at the disease progression during follow-up, as the same dose as the last chemotherapy of initial 6 cycles. | Drug | A, B |
Primary outcome
Overall survial in the two treatment arms
Time frame: During study period
1 secondary outcome
Response rate, toxicity, duration of response, time to progression, Quality of life in the two treatment arms,the effect of CYP2A6 genetic polymorphisms on the pharmacokinetics, treatment efficacy and toxicity
Time frame: During study period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2008.
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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.
Sook Ryun Park, M.D. principal investigator
National Cancer Center, Korea
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 S-1,oxaliplatin in people with Stomach Neoplasms, run by National Cancer Center, Korea at 1 site in South Korea.
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 17 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 7 Jan 2008. 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 South Korea. 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 Sook Ryun Park, M.D. (+82-31-920-1609, sukryun73@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survial in the two treatment arms (time frame: During study period). 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 7 Jan 2008.