Gastric CancerPhase 2NCT01426646
S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy to Treat Gastric Cancer
A Phase 2 study testing S-1 and S-1 plus cisplatin in people with Gastric Cancer, run by Kyungpook National University Hospital at 2 sites in South Korea.
Trial summary
Although there has been some progress in chemotherapy for metastatic gastric cancer, no standard regimen of adjuvant chemotherapy is available, and many clinical trials have produced contradictory results. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1 and S-1 plus cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2011to Sep 2016
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years
- Histologically proven adenocarcinoma of the stomach
- Curative D2 lymphadenectomy resection for gastric cancer, who can be randomized to either study arm within 6 weeks after surgery
- Stage II, III and IV (M0)(AJCC 7th edition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- No prior chemotherapy or radiotherapy
- Adequate bone marrow, renal, and liver function
Who cannot join
- Pregnant or lactating women.
- Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Any evidence of metastatic disease (including presence of tumor cells in the ascites).
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- Major surgery within 4 weeks prior to study treatment start, or lack of complete recovery from the effects of major surgery.
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- History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
- Lack of physical integrity of the upper gastrointestinal tract or those who have malabsorption syndrome likely to influence absorption of capecitabine, or inability to take oral medication.
- Organ allografts requiring immunosuppressive therapy.
- Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
- Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented dihydropyrimidine dehydrogenase (DPD) deficiency) or patients with known DPD deficiency.
- Hypersensitivity to platinum compounds or any of the components of the study medications.
- Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
- Blood transfusions or growth factors to aid hematologic recovery within 2 weeks prior to study treatment start.
- Requirement for concurrent use of the antiviral agent sorivudine (antiviral) or chemically related analogues, such as brivudine.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites, 2 recruiting
- Recruiting
Donga university hospital
Busan, 602-715
Hyuk-Chan Kwon, Professor
Hyuk-Chan Kwon, Professor
- Recruiting
Ulsan University Hospital
Ulsan, 682-714
Jin Ho Baek, Professor
Jin-Ho Baek, Professor
About this study
Official title: Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
Although there has been some progress in chemotherapy for metastatic gastric cancer, no standard regimen of adjuvant chemotherapy is available, and many clinical trials have produced contradictory results. The majority of randomized clinical trials studying adjuvant chemotherapy in gastric cancer have been underpowered, involved low-volume centers, or used ineffective chemotherapy regimens. As a result, well-designed multicenter trials are still needed. The ACTS-GC trial, which demonstrated the efficacy of S-1 for stage II-III gastric cancer patients who underwent curative resection with extended lymph-node dissection (D2), may be valid in countries where D2 surgery is considered the standard of care. S-1 improved the 3-year overall survival from 70.1% for surgery alone to 80.1%. However, 3-year overall survival in stage IIIA and stage IIIB patients receiving S-1 were 77.4% and 63.4%, respectively, which are less satisfactory compared to the rate for stage II (90.7%). Based on the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial, further investigation is needed for more effective postoperative treatment of patients with stage IIIB and IV (M0) cancer. Therefore, the researchers investigated the efficacy and safety of S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively resected gastric adenocarcinoma.
Read the detailed description
This controlled study is designed to evaluate the efficacy of S-1 on survival compared with S-1 plus cisplatin. Patients will be randomly assigned to receive either surgery followed by treatment with S-1 plus cisplatin or surgery followed by treatment with S-1 within 42 days after curative resection. To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
- Conditions
- Gastric Cancer
- Being tested
- S-1, S-1 plus cisplatin
- Keywords
- gastric cancer, S-1, cisplatin, adjuvant chemotherapy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1Drug
Also called TS-1
S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.
S-1 plus cisplatinDrug
Also called TS-1, cisplatin
S-1 plus cisplatin every 3 weeks, a total of eight cycles
- S-1: 40mg/m2 orally twice daily (days 1-14)
- Cisplatin: 60mg/m2 IV on day 1
| Study group | Role | What they receive |
|---|---|---|
| S-1 treatment | Experimental | S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles. Receives: Drug: S-1 |
| S-1 plus cisplatin treatment | Experimental | S-1 plus cisplatin every 3 weeks, A total of eight cycles
* S-1: 40mg/m2 orally twice daily (days 1-14)
* Cisplatin: 60mg/m2 IV on day 1 Receives: Drug: S-1 plus cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse-free survival
RFS was defined as the time from the date of surgery to relapse or death from any cause.
Measured: 3 years from enrollment.
Secondary outcomes (1)
Overall survival
OS was defined as the time from the date of surgery to death from any cause.
Measured: 3 years from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionSep 2014 (estimated)
- Study completionSep 2016 (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.
- 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
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byung Woog Kang, Kyungpook National University Hospital
- Investigators
- Wansik Yu, Professor, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01426646
- Sponsor's protocol ID
- ACSPGC-01
- Status last verified
- Jan 2012
- First submitted
- 18 Jan 2011
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Phase II Trial of S-1 Versus S-1 Plus Cisplatin as an Adjuvant Chemotherapy After Curative Resection of Stage II-IV(M0) Gastric Cancer
- ClinicalTrials.gov ID
- NCT01426646
- Acronym / sponsor ID
- ACSPGC-01
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, S-1, cisplatin, adjuvant chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 31 Aug 2011 (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.
Although there has been some progress in chemotherapy for metastatic gastric cancer, no standard regimen of adjuvant chemotherapy is available, and many clinical trials have produced contradictory results. The majority of randomized clinical trials studying adjuvant chemotherapy in gastric cancer have been underpowered, involved low-volume centers, or used ineffective chemotherapy regimens. As a result, well-designed multicenter trials are still needed. The ACTS-GC trial, which demonstrated the efficacy of S-1 for stage II-III gastric cancer patients who underwent curative resection with extended lymph-node dissection (D2), may be valid in countries where D2 surgery is considered the standard of care. S-1 improved the 3-year overall survival from 70.1% for surgery alone to 80.1%. However, 3-year overall survival in stage IIIA and stage IIIB patients receiving S-1 were 77.4% and 63.4%, respectively, which are less satisfactory compared to the rate for stage II (90.7%). Based on the unsatisfactory outcome among later stage patients in the ACTS-GC adjuvant trial, further investigation is needed for more effective postoperative treatment of patients with stage IIIB and IV (M0) cancer. Therefore, the researchers investigated the efficacy and safety of S-1 versus S-1 plus cisplatin as adjuvant chemotherapy in patient with curatively resected gastric adenocarcinoma.
Detailed description
This controlled study is designed to evaluate the efficacy of S-1 on survival compared with S-1 plus cisplatin. Patients will be randomly assigned to receive either surgery followed by treatment with S-1 plus cisplatin or surgery followed by treatment with S-1 within 42 days after curative resection. To assess the efficacy, data on recurrence and survival will be collected from the time of enrollment until 5 years after surgery. To evaluate safety, data on adverse events will be collected from the time of enrollment until 1 year after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1 treatment | Experimental | Drug: S-1S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles. |
| S-1 plus cisplatin treatment | Experimental | Drug: S-1 plus cisplatinS-1 plus cisplatin every 3 weeks, A total of eight cycles * S-1: 40mg/m2 orally twice daily (days 1-14) * Cisplatin: 60mg/m2 IV on day 1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-70 years
- Histologically proven adenocarcinoma of the stomach
- Curative D2 lymphadenectomy resection for gastric cancer, who can be randomized to either study arm within 6 weeks after surgery
- Stage II, III and IV (M0)(AJCC 7th edition)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
Key exclusion criteria (16 listed)
- Pregnant or lactating women.
- Women of childbearing potential with either a positive or no pregnancy test at baseline. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-child bearing potential.
- Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study.
- Any evidence of metastatic disease (including presence of tumor cells in the ascites).
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
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-1Also: TS-1S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles. | Drug | S-1 treatment |
| S-1 plus cisplatinAlso: TS-1, cisplatinS-1 plus cisplatin every 3 weeks, a total of eight cycles * S-1: 40mg/m2 orally twice daily (days 1-14) * Cisplatin: 60mg/m2 IV on day 1 | Drug | S-1 plus cisplatin treatment |
Primary outcome
Relapse-free survival
Time frame: 3 years from enrollment.
RFS was defined as the time from the date of surgery to relapse or death from any cause.
1 secondary outcome
Overall survival
Time frame: 3 years from enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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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.
Wansik Yu, Professor principal investigator
Kyungpook National University Hospital
2 sites 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 and S-1 plus cisplatin in people with Gastric Cancer, run by Kyungpook National University Hospital at 2 sites 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 16 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 5 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Byung Woog Kang, Professor (+82-10-9216-2633, bwkang@knu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relapse-free survival (time frame: 3 years from enrollment.). 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 5 Jan 2012.