Advanced Gastric CancerPhase 3NCT00915382
Trial of 3-weekly Versus 5-weekly Schedule of S-1 Plus Cisplatin in Gastric Cancer: SOS
A Phase 3 study testing S-1 and cisplatin in people with Advanced Gastric Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The urgent need for a new effective therapy with better safety profile for the metastatic gastric cancer patients and promising results observed so far in the studies with S-1 plus cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a 3-weekly schedule to a 5-weekly schedule of… Read more about this study
- Who is it for?
- Ages 18 to 74 years
- Conditions the study is for
- Advanced Gastric Cancer
- What is being tested?
- S-1 and cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 625 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to May 2013
- 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 18 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically documented metastatic or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
- Age 18 to 74 years old
- Performance status (ECOG scale) 0-2
- No significant problems for oral intake and drug administration
- At least one measurable or evaluable disease defined by RECIST
- Adequate bone marrow function (ANC ≥ 1,500/uL, Platelet ≥ 100,000/ uL, Hb ≥ 9.0 g/dl)
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- Adequate renal function: serum creatinine ≤ UNL (if serum creatinine > UNL, creatinine clearance should be ≥ 60 mL/min)
- Adequate hepatic function (Total bilirubin < 2 x UNL and AST/ALT levels < 3 x UNL without liver metastasis,total bilirubin < 3x ULN and AST/ALT levels < 5 x UNL with liver metastasis)
- Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) is allowed if at least 6 months has elapsed between completion of adjuvant/neoadjuvant therapy and enrolment into the study) and cisplatin was not used before
- Patients should sign a written informed consent before study entry
Who cannot join
- Tumor type other than adenocarcinoma
- Previously exposed to any fluropymidine within 6 months before the study
- Previously exposed to Platinum therapy regardless of its period and/or duration
- Microscopic residual disease only after noncurative gastrectomy with R1 resection (resection margin positive)
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
- Prior radiotherapy was administered to target lesions selected for this study, or radiotherapy to the non-target lesions has been completed within 4 weeks before randomization
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- Presence of CNS metastasis
- Major surgery within 4 weeks before initiation of study treatment or lack of complete recovery from the effects of major surgery (patient received curative operation or RFA for metastatic disease)
- Serious illness or medical conditions:
- Congestive heart failure (NYHA class III or IV)
- Unstable angina or myocardial infarction within the past 12 months
- Significant arrhythmias requiring medication and conduction abnormality such as over 2nd degree AV block
- Uncontrolled hypertension
- Hepatic cirrhosis (≥ Child class B)
- Interstitial pneumonia
- Pulmonary adenomatosis
- Psychiatric disorder that may interfere with protocol compliance
- Unstable diabetes mellitus
- Uncontrolled ascites or pleural effusion
- Active infection
- Receiving a concomitant treatment interacting with S-1 or cisplatin:
- Flucytosine (a fluorinated pyrimidine antifungal agent)
- Antivirals such as sorivudine, ramivudine, brivudine or other chemically related agents, warfarin, phenprocoumon, phenytoin, allopurinol
- Pregnant or lactating woman
- Women of child bearing potential not using a contraceptive method
- Sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential
- Any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Oncology, Asan Medical Center
Seoul, 138-736
About this study
Official title: Phase III Trial of 3-weekly vs. 5-weekly Schedule of S-1 Plus Cisplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer.
The urgent need for a new effective therapy with better safety profile for the metastatic gastric cancer patients and promising results observed so far in the studies with S-1 plus cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a 3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the first-line treatment for AGC patients.
The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1 plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is progression-free survival. This is an open label, randomized, multi-center, non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.
Read the detailed description
The primary endpoint of this study is Progression Free Survival (PFS). It is defined as the time from the date of randomization to the time of disease progression as assessed by the investigators, or death due to any cause. The primary goal of this study is to compare two different schedules of S-1 plus cisplatin combination treatments (3-weekly regimen vs. 5-weekly regimen) for advanced gastric cancer with respect to the PFS based on the hybrid design where we can test superiority and non-inferiority in the same trial (Reference: Journal of Clinical Oncology 25: 5019-5023, 2007, Boris Freidlin, et el). First, the non-inferiority hypothesis will be tested based on the non-inferiority margin 1.15. If the inferiority cannot be rejected(meaning non-inferiority is proven) then the superiority will be tested. If the superiority test is positive, then superiority is concluded; otherwise non-inferiority without superiority will be concluded.
The sample size was calculated from the following consideration:
For non-inferiority test: non-inferiority margin 1.15, 10 percent reduction of hazard ratio, power 80 percent, alpha 0.025, accrual period 36 months, follow-up period 12 months, and the expected median PFS of 6 months for 5 weekly regimen were assumed. Based on the above considerations, total of 560 patients will be need. With 10 percent follow-up loss, we need 622 patients.
For superiority test: the median PFS for 5-weekly regimen is expected to be 6 months and 7.5 months for 3-weekly regimen. With sample size of 560 patients calculated above, for detecting 1.5 months difference in the median PFS between the two groups , we will have 81 percent of power, one-sided 5 percent type I error. Using the log rank test assuming exponential underlying distribution, accrual period of 36 months, minimum of 12 months follow-up after the last enrolment, 516 events will be needed to show the superiority of 3 week cycle.
- Conditions
- Advanced Gastric Cancer
- Being tested
- S-1 and cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 and cisplatinDrug
Also called TS-1 and cisplatin
S-1: 80 mg/m2/day po on Days 1-14
cisplatin: 60 mg/m2 iv on Day 1
S-1 and cisplatinDrug
Also called TS-1 and cisplatin
S-1: 80 mg/day with BSA less than 1.25 m2, 100 mg/day with BSA more than 1.25 m2 and less than 1.5 m2, 120 mg/day with BSA more than 1.5 m2 on Days 1-21 and
cisplatin: 60 mg/m2 iv on Day 1 or 8
| Study group | Role | What they receive |
|---|---|---|
| 3 weekly regimen of S-1 and cisplatin | Active comparator | Not described Receives: Drug: S-1 and cisplatin |
| 5 weekly regimen of S-1 and cisplatin | Active comparator | Not described Receives: Drug: S-1 and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Measured: accrual of patients for 36 months, followup of the last patient for 12 months
Secondary outcomes (1)
overall survival
Measured: accrual of patients for 36 months, followup of the last patient for 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startJan 2009
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Gastric CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 625 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Kyungpook National University Hospital, Seoul Veterans Hospital, National Cancer Center, Korea, Ulsan University Hospital, Inje University, Chonbuk National University Hospital, Gachon University Gil Medical Center, Korea Cancer Center Hospital, Yeungnam University College of Medicine, Hallym University Medical Center, Chonnam National University Hospital
- Responsible party
- Principal investigator, Yoon-Koo Kang, Asan Medical Center
- Investigators
- Yoon-Koo Kang, MD, PhD, Principal investigator, Asan Medical Center, Seoul, KoreaWon Ki Kang, M.D.PhD., Principal investigator, Samsung Medical Center, Seoul, KoreaJong Kwang Kim, M.D.PhD, Principal investigator, Kyungpook National University Hospital, KoreaYoung Iee Park, M.D.PhD, Principal investigator, National Cancer Center, KoreaJin Ho Baek, M.D.PhD., Principal investigator, Ulsan University Hospital, KoreaChang Hak Sohn, M.D.PhD., Principal investigator, Inje University Pusan Paik Hospital, KoreaEun Ki Song, M.D.PhD., Principal investigator, Chonbuk National University Hospital, KoreaDong Bok Shin, M.D.PhD., Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915382
- Sponsor's protocol ID
- AMC0902
- Status last verified
- Jan 2020
- First submitted
- 5 Jun 2009
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ryu MH, Baba E, Lee KH, Park YI, Boku N, Hyodo I, Nam BH, Esaki T, Yoo C, Ryoo BY, Song EK, Cho SH, Kang WK, Yang SH, Zang DY, Shin DB, Park SR, Shinozaki K, Takano T, Kang YK; SOS study investigators. Comparison of two different S-1 plus cisplatin dosing schedules as first-line chemotherapy for metastatic and/or recurrent gastric cancer: a multicenter, randomized phase III trial (SOS). Ann Oncol. 2015 Oct;26(10):2097-101. doi: 10.1093/annonc/mdv316. Epub 2015 Jul 27.
PubMed 26216386
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Trial of 3-weekly vs. 5-weekly Schedule of S-1 Plus Cisplatin Combination Chemotherapy for First Line Treatment of Advanced Gastric Cancer.
- ClinicalTrials.gov ID
- NCT00915382
- Acronym / sponsor ID
- AMC0902
- Conditions
- Advanced Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 625 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Kyungpook National University Hospital, Seoul Veterans Hospital, National Cancer Center, Korea, Ulsan University Hospital, Inje University, Chonbuk National University Hospital, Gachon University Gil Medical Center, Korea Cancer Center Hospital, Yeungnam University College of Medicine, Hallym University Medical Center, Chonnam National University Hospital
- Study start
- Jan 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 8 Jun 2009 (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 urgent need for a new effective therapy with better safety profile for the metastatic gastric cancer patients and promising results observed so far in the studies with S-1 plus cisplatin combination in advanced gastric cancer (AGC) strongly warrants the comparison of a 3-weekly schedule to a 5-weekly schedule of S-1 plus cisplatin as a standard regimen in the first-line treatment for AGC patients.
The objectives of this study are to compare a 3-weekly schedule to a 5-weekly schedule of S-1 plus Cisplatin combination in terms of efficacy, quality of life and safety in patients with previously untreated advanced or recurrent unresectable gastric cancer. Primary endpoint is progression-free survival. This is an open label, randomized, multi-center, non-inferiority/superiority (of 3-weekly regimen over 3-weekly regimen) hybrid study.
Detailed description
The primary endpoint of this study is Progression Free Survival (PFS). It is defined as the time from the date of randomization to the time of disease progression as assessed by the investigators, or death due to any cause. The primary goal of this study is to compare two different schedules of S-1 plus cisplatin combination treatments (3-weekly regimen vs. 5-weekly regimen) for advanced gastric cancer with respect to the PFS based on the hybrid design where we can test superiority and non-inferiority in the same trial (Reference: Journal of Clinical Oncology 25: 5019-5023, 2007, Boris Freidlin, et el). First, the non-inferiority hypothesis will be tested based on the non-inferiority margin 1.15. If the inferiority cannot be rejected(meaning non-inferiority is proven) then the superiority will be tested. If the superiority test is positive, then superiority is concluded; otherwise non-inferiority without superiority will be concluded.
The sample size was calculated from the following consideration:
For non-inferiority test: non-inferiority margin 1.15, 10 percent reduction of hazard ratio, power 80 percent, alpha 0.025, accrual period 36 months, follow-up period 12 months, and the expected median PFS of 6 months for 5 weekly regimen were assumed. Based on the above considerations, total of 560 patients will be need. With 10 percent follow-up loss, we need 622 patients.
For superiority test: the median PFS for 5-weekly regimen is expected to be 6 months and 7.5 months for 3-weekly regimen. With sample size of 560 patients calculated above, for detecting 1.5 months difference in the median PFS between the two groups , we will have 81 percent of power, one-sided 5 percent type I error. Using the log rank test assuming exponential underlying distribution, accrual period of 36 months, minimum of 12 months follow-up after the last enrolment, 516 events will be needed to show the superiority of 3 week cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 weekly regimen of S-1 and cisplatin | Active comparator | Drug: S-1 and cisplatin |
| 5 weekly regimen of S-1 and cisplatin | Active comparator | Drug: S-1 and cisplatin |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically documented metastatic or recurrent gastric adenocarcinoma including adenocarcinoma of the gastro-esophageal junction
- Age 18 to 74 years old
- Performance status (ECOG scale) 0-2
- No significant problems for oral intake and drug administration
- At least one measurable or evaluable disease defined by RECIST
Key exclusion criteria (27 listed)
- Tumor type other than adenocarcinoma
- Previously exposed to any fluropymidine within 6 months before the study
- Previously exposed to Platinum therapy regardless of its period and/or duration
- Microscopic residual disease only after noncurative gastrectomy with R1 resection (resection margin positive)
- Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin or prior malignancy treated more than 5 years ago without recurrence)
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 and cisplatinAlso: TS-1 and cisplatinS-1: 80 mg/m2/day po on Days 1-14 cisplatin: 60 mg/m2 iv on Day 1 | Drug | 3 weekly regimen of S-1 and cisplatin |
| S-1 and cisplatinAlso: TS-1 and cisplatinS-1: 80 mg/day with BSA less than 1.25 m2, 100 mg/day with BSA more than 1.25 m2 and less than 1.5 m2, 120 mg/day with BSA more than 1.5 m2 on Days 1-21 and cisplatin: 60 mg/m2 iv on Day 1 or 8 | Drug | 5 weekly regimen of S-1 and cisplatin |
Primary outcome
progression-free survival
Time frame: accrual of patients for 36 months, followup of the last patient for 12 months
1 secondary outcome
overall survival
Time frame: accrual of patients for 36 months, followup of the last patient for 12 months
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 Jan 2020.
- Derived from this study: PubMed 26216386Ryu MH, Baba E, Lee KH, Park YI, Boku N, Hyodo I, Nam BH, Esaki T, Yoo C, Ryoo BY, Song EK, Cho SH, Kang WK, Yang SH, Zang DY, Shin DB, Park SR, Shinozaki K, Takano T, Kang YK; SOS study investigators. Comparison of two different S-1 plus cisplatin dosing schedules as first-line chemotherapy for metastatic and/or recurrent gastric cancer: a multicenter, randomized phase III trial (SOS). Ann Oncol. 2015 Oct;26(10):2097-101. doi: 10.1093/annonc/mdv316. Epub 2015 Jul 27.
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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.
Yoon-Koo Kang, MD, PhD principal investigator
Asan Medical Center, Seoul, Korea
Won Ki Kang, M.D.PhD. principal investigator
Samsung Medical Center, Seoul, Korea
Jong Kwang Kim, M.D.PhD principal investigator
Kyungpook National University Hospital, Korea
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 S-1 and cisplatin in people with Advanced Gastric Cancer, run by Asan Medical Center 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 10 inclusion and 27 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 Jan 2020. 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 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?
progression-free survival (time frame: accrual of patients for 36 months, followup of the last patient for 12 months). 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 NCT00915382, which also lists 1 linked publication.
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 2020.