Stomach NeoplasmsPhase 2NCT00580359
S-1 vs Capecitabine in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
A Phase 2 study testing S-1, capecitabine in people with Stomach Neoplasms, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
This study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Stomach Neoplasms
- What is being tested?
- S-1, capecitabine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2007to Jun 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
- Age of 70-85 years with Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or age ≥65 and <70 with ECOG performance status ≥ 2
- Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) Measurable lesions:
- Lesions that can be accurately measured in at least one dimension by any of the following:
- Computed tomography (CT) of abdomen, pelvis or thorax, if the longest diameter to be recorded is at least 10 mm with spiral CT
- Chest x-ray, if the lung lesion to be recorded is clearly defined and surrounded by aerated lung and the diameter to be recorded is at least 20 mm- Physical examination, if the clinically detected lesions are superficial (e.g., skin nodule and palpable lymph nodes) and at least 10 mm
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- No prior chemotherapy for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant chemotherapy is allowed at least 6 months has relapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the therapy; prior S-1 or capecitabine is not allowed)
- Adequate major organ function including the following:
- Hematopoietic function:
- absolute neutrophil count (ANC)≥1,500/mm3,
- Platelet ≥ 100,000/mm3,
- Hepatic function:
- serum bilirubin =< 1.5 x upper limit of normal (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
- Inadequate cardiovascular function:
- New York Heart Association class III or IV heart disease
- Unstable angina or myocardial infarction within the past 6 months
- History of significant ventricular arrhythmia requiring medication with antiarrhythmics or significant conduction system abnormality
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- 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
- Known dihydropyrimidine dehydrogenase deficiency
- Patients receiving a concomitant treatment with drugs interacting with S-1 or capecitabine such as flucytosine, phenytoin, warfarin, lamivudine, or allopurinol et al.
- Patients with known active infection with HIV, HBV, or HCV
- 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
So Yun Park, MS, +82-31-920-2307, tomongmong@naver.com
About this study
Official title: A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
This study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. The randomization will be stratified by age (70-85 years versus 65 years and < 70 years) and performance status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2 and in ³65 years and <70 years, ECOG performance status 2 versus 3.
- S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
- Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment will be administered every 3 weeks and will be continued in the absence of disease progression or unacceptable toxicity.
- Conditions
- Stomach Neoplasms
- Being tested
- S-1, capecitabine
- Keywords
- Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, Capecitabine
- 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, capecitabineDrug
S-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Receives: Drug: S-1, capecitabine |
| B | Active comparator | Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Receives: Drug: S-1, capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate each response rate of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer
Measured: During Chemotherapy
Secondary outcomes (1)
the duration of response, time to progression, progression-free survival,overall survival,the safety profiles,the quality of life,the CYP2A6 genetic polymorphism and its association with clinical outcomes in patients treated with S-1
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 posted24 Dec 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2009 (estimated)
- Study completionJun 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
- 96 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
- NCT00580359
- Sponsor's protocol ID
- NCCCTS-07-263
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 8 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of S-1 Versus Capecitabine as First-Line Chemotherapy in the Elderly and/or Poor Performance Status Patients With Recurrent or Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT00580359
- Acronym / sponsor ID
- NCCCTS-07-263
- Conditions
- Stomach Neoplasms
- Keywords
- Stomach Neoplasms, Secondary, Combination chemotherapy, S-1, Capecitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- May 2007
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 24 Dec 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.
This study is an open-label, single-center, and randomized phase II study designed to evaluate each efficacy and safety of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer. The randomization will be stratified by age (70-85 years versus 65 years and < 70 years) and performance status, which is dependent on age group; in 70-85 years, ECOG performance status 0-1 versus 2 and in ³65 years and <70 years, ECOG performance status 2 versus 3.
- S-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning)
- Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) Treatment will be administered every 3 weeks and will be continued in the absence of disease progression or unacceptable toxicity.
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, capecitabineS-1 40mg/m2 orally twice daily on days 1 (evening) - 15 (morning) |
| B | Active comparator | Drug: S-1, capecitabineCapecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning) |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Histologically or cytologically confirmed gastric adenocarcinoma with recurrent or metastatic disease
- Age of 70-85 years with Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or age ≥65 and <70 with ECOG performance status ≥ 2
- Measurable disease as defined by Response Evaluation Criteria In Solid Tumors (RECIST) Measurable lesions:
- No prior chemotherapy for recurrent and/or metastatic disease (prior adjuvant/neoadjuvant chemotherapy is allowed at least 6 months has relapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the therapy; prior S-1 or capecitabine is not allowed)
- Adequate major organ function including the following:
Key exclusion criteria (15 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
- Inadequate cardiovascular function:
- 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
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, capecitabineS-1 40mg/m2 orally twice daily on days 1(evening) - 15 (morning)every 3 weeks, until disease progression, Capecitabine 1250mg/m2 orally twice daily on days 1 (evening) - 15 (morning)every 3 weeks, until disease progression | Drug | A, B |
Primary outcome
To evaluate each response rate of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer
Time frame: During Chemotherapy
1 secondary outcome
the duration of response, time to progression, progression-free survival,overall survival,the safety profiles,the quality of life,the CYP2A6 genetic polymorphism and its association with clinical outcomes in patients treated with S-1
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 8 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, capecitabine 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 17 inclusion and 15 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 8 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?
To evaluate each response rate of S-1 and capecitabine in the elderly and/or poor performance status patients with recurrent or metastatic gastric cancer (time frame: During Chemotherapy). 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 8 Jan 2008.