Gastric CancerPhase 3NCT00150670
Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
A Phase 3 study testing TS-1 and cisplatin and TS-1 in people with Gastric Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
Trial summary
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- TS-1 and cisplatin and TS-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2002to Dec 2006
- Phase
- Phase 3
- 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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma
- Unresectable and recurrent gastric cancer
- Age 20 to 74
- Performance status 0, 1, or 2 (ECOG)
- Life expectancy 3 months
- No prior chemotherapy or radiotherapy for gastric cancer
Show all 11Show fewer
- Able to take oral medication
- Evaluable or not evaluable lesion had already checked more than 28 days before participated in this study
- Hematopoietic Absolute granulocyte count lower limit of normal-12,000/mm^3 Platelet ≥ 100,000/mm^3 Hemoglobin ≥ 8.0 g/dL
- Hepatic AST and ALT ≤ 100 U/L ALP ≤ 2 times upper limit of normal (ULN) Bilirubin ≤ 1.5 mg/dL
- Renal Plasma creatinine ≤ ULN Creatinine clearance ≥ 50 mL/min
Who cannot join
- Pregnant or nursing
- Bleeding from gastrointestinal tract or no diarrhea
- Hypersensitivity to TS-1 or CDDP
- Psychiatric disorder that would preclude study compliance or giving informed consent
- Severe acute or chronic medical or psychiatric condition or laboratory abnormality
- Serious illness or medical condition
- Brain metastasis
- Ascites requiring drainage
Trial locations and contacts
1 site in 1 country.
Japan1 site
East Hospital, Kitasato University
2-1-1, Asamizodai, Sagamihara, Kanagawa
About this study
This study aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.
Read the detailed description
This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.
- Conditions
- Gastric Cancer
- Being tested
- TS-1 and cisplatin, TS-1
- Keywords
- Stomach cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TS-1 and cisplatinDrug
TS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle.
TS-1Drug
TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | TS-1 and cisplatin Receives: Drug: TS-1 and cisplatin |
| 2 | Active comparator | TS-1 Receives: Drug: TS-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: every course for first three courses, then every other course
Secondary outcomes (1)
Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile
Measured: every course for first three courses, then every other course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Wasaburo Koizumi, MD, PHD, Principal investigator, East Hospital, Kitasato University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00150670
- Sponsor's protocol ID
- 91023039
- Status last verified
- Jul 2011
- First submitted
- 7 Sep 2005
- Last updated
- 7 Jul 2011
- Results posted
- No
Publications
Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.
PubMed 18282805Arai H, Takeuchi M, Ichikawa W, Shitara K, Sunakawa Y, Oba K, Koizumi W, Sakata Y, Furukawa H, Yamada Y, Takeuchi M, Fujii M. Correlation of multiple endpoints in the first-line chemotherapy of advanced gastric cancer: Pooled analysis of individual patient data from Japanese Phase III trials. Cancer Med. 2024 Jan;13(1):e6818. doi: 10.1002/cam4.6818. Epub 2023 Dec 23.
PubMed 38140879
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase III Study of TS-1 Alone Versus TS-1 Plus CDDP in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT00150670
- Acronym / sponsor ID
- 91023039
- Conditions
- Gastric Cancer
- Keywords
- Stomach cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2002
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 8 Sep 2005 (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 aimed to verify the survival benefit of TS-1 plus CDDP combination chemotherapy compared with the monotherapy by TS-1 alone.
Detailed description
This is a randomized, controlled, open-label, parallel, multicenter study. Patients are stratified according to 3 factors ; performance status (ECOG scale: 0, 1, 2), disease stage (unresectable gastric cancer or recurrent gastric cancer (received prior adjuvant chemotherapy or not)) and participating center. Patients are randomized to one of two treatment arms. Arm A: Patients receive oral TS-1 twice daily on days 1-28 followed by 14 days rest. Treatment is repeated every 42 days for up to 4 courses. Arm B: Patients receive CDDP iv on day 8 and oral TS-1 twice daily on days 1-21 followed by 14 days rest. Treatment is repeated every 35 days for up to 5 courses. Patients are followed every 6 months for up to 2 years from the day they participates in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: TS-1 and cisplatinTS-1 and cisplatin |
| 2 | Active comparator | Drug: TS-1TS-1 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed adenocarcinoma
- Unresectable and recurrent gastric cancer
- Age 20 to 74
- Performance status 0, 1, or 2 (ECOG)
- Life expectancy 3 months
Key exclusion criteria (8 listed)
- Pregnant or nursing
- Bleeding from gastrointestinal tract or no diarrhea
- Hypersensitivity to TS-1 or CDDP
- Psychiatric disorder that would preclude study compliance or giving informed consent
- Severe acute or chronic medical or psychiatric condition or laboratory 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 |
|---|---|---|
| TS-1 and cisplatinTS-1(40-60 mg per body surface area) was given orally, twice daily for 3 consecutive weeks, and 60 mg/m2 cisplatin was given intravenously on day 8, followed by a 2-week rest period, within a 5-week cycle. | Drug | 1 |
| TS-1TS-1(40-60 mg per body surface area) was given orally, twice daily for 4 consecutive weeks, followed by a 2-week rest period, within a 6-week cycle. | Drug | 2 |
Primary outcome
Overall survival
Time frame: every course for first three courses, then every other course
1 secondary outcome
Overall response rate, lesion-directed response rate, time to treatment failure (TTF), hospitalization-free survival period within the periods of TTF, and safety profile
Time frame: every course for first three courses, then every other course
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 7 Jul 2011.
- Results publication: PubMed 18282805Koizumi W, Narahara H, Hara T, Takagane A, Akiya T, Takagi M, Miyashita K, Nishizaki T, Kobayashi O, Takiyama W, Toh Y, Nagaie T, Takagi S, Yamamura Y, Yanaoka K, Orita H, Takeuchi M. S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial. Lancet Oncol. 2008 Mar;9(3):215-21. doi: 10.1016/S1470-2045(08)70035-4. Epub 2008 Feb 20.
- Derived from this study: PubMed 38140879Arai H, Takeuchi M, Ichikawa W, Shitara K, Sunakawa Y, Oba K, Koizumi W, Sakata Y, Furukawa H, Yamada Y, Takeuchi M, Fujii M. Correlation of multiple endpoints in the first-line chemotherapy of advanced gastric cancer: Pooled analysis of individual patient data from Japanese Phase III trials. Cancer Med. 2024 Jan;13(1):e6818. doi: 10.1002/cam4.6818. Epub 2023 Dec 23.
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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.
Wasaburo Koizumi, MD, PHD principal investigator
East Hospital, Kitasato University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TS-1 and cisplatin and TS-1 in people with Gastric Cancer, run by Taiho Pharmaceutical Co., Ltd. at 1 site in Japan.
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 8 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 7 Jul 2011. 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 Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Overall survival (time frame: every course for first three courses, then every other course). 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 NCT00150670, which also lists 2 linked publications.
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 Jul 2011.