Gastric CancerPhase 2NCT02090153
Study of S-1 Plus LV for Advanced Gastric Cancer
A Phase 2 study testing S-1 and LV in people with Gastric Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- S-1 and LV
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- Jul 2011to Mar 2014
- 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 confirmed metastatic or recurrent gastric cancer
- with at least one measurable lesion by RECIST criteria
- an age of ≥ 18
- adequate oral intake
- no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if finished 6 months before enrollment)
- an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- adequate bone marrow function, hepatic function and renal functions
Who cannot join
- a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
- serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)
- extensive bone metastasis, brain metastasis or meningeal metastasis
- another synchronous cancer
- surgery within 3 weeks before enrollment
- participating in other clinical studies
- women who were or to be pregnant, nursing infants, and men who were to conceive children
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer
The purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.
Read the detailed description
Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.
- Conditions
- Gastric Cancer
- Being tested
- S-1, LV
- Keywords
- Advance Gastric Cancer,, S-1 plus leucovorin,, ORR,, OS,, TTP,, TTF,, Adverse events,, Pharmacokinetics
- 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 tegafur/gimeracil/oteracil potassium
40~60mg bid，d1~7 q2W
LVDrug
Also called Leucovorin
LV is given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.
| Study group | Role | What they receive |
|---|---|---|
| S-1 plus LV | Experimental | All patients were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Receives: Drug: S-1; Drug: LV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.
Measured: 1 year
Secondary outcomes (5)
Progression free survival (PFS)
Progression-free survival (PFS) was determined from the date of treatment to progression or death
Measured: 1-1.5 years
Overall survival (OS)
Overall survival (OS) was calculated from the date of treatment to death from any cause or the last date of follow-up.
Measured: 1-2.5 years
Time to treatment failure (TTF)
Time to treatment failure (TTF) was determined from the date of treatment to progression, death, refusal or interruption due to adverse events.
Measured: 1 year
Disease control rate
Disease control rate equals the rate of patients with CR+PR+SD.
Measured: 1 year
Adverse Events (AEs)
All treatment-related adverse events (AEs) were categorized according to the National Cancer Institute's Common Terminology Criteria for Adverse Events.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startJul 2011
- Primary completionJul 2013
- Study completionMar 2014
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.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Ruihua Xu, Sun Yat-sen University
- Investigators
- Ruihua Xu, Professor, Principal investigator, SunYat-sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090153
- Sponsor's protocol ID
- SL for AGC
- Status last verified
- Mar 2014
- First submitted
- 12 Mar 2014
- Last updated
- 18 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Koizumi W, Boku N, Yamaguchi K, Miyata Y, Sawaki A, Kato T, Toh Y, Hyodo I, Nishina T, Furuhata T, Miyashita K, Okada Y. Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer. Ann Oncol. 2010 Apr;21(4):766-771. doi: 10.1093/annonc/mdp371. Epub 2009 Oct 14.
PubMed 19828562He MM, Zhang DS, Wang F, Wang ZX, Yuan SQ, Wang ZQ, Luo HY, Ren C, Qiu MZ, Jin Y, Wang DS, Chen DL, Zeng ZL, Li YH, He YY, Hao YT, Guo P, Wang FH, Zeng YX, Xu RH. Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway. Cancer Chemother Pharmacol. 2017 Jan;79(1):69-79. doi: 10.1007/s00280-016-3209-1. Epub 2016 Dec 2.
PubMed 27913881
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of S-1 Plus Leucovorin (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic and Recurrent Gastric Cancer
- ClinicalTrials.gov ID
- NCT02090153
- Acronym / sponsor ID
- SL for AGC
- Conditions
- Gastric Cancer
- Keywords
- Advance Gastric Cancer,, S-1 plus leucovorin,, ORR,, OS,, TTP,, TTF,, Adverse events,, Pharmacokinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Taiho Pharmaceutical Co., Ltd.
- Study start
- Jul 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 18 Mar 2014 (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 purpose of this study is to evaluate the effectiveness and safety of S-1 plus Leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.
Detailed description
Patients enrolled in this study were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. Treatment was continued until progressive disease (PD), unacceptable toxicity or patient refusal.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-1 plus LV | Experimental | Drug: S-1, Drug: LVAll patients were orally treated with S-1 in doses of 40 mg (body surface area (BSA)<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-7 in combination with LV given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. Treatment courses were repeated every 2 weeks. |
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 confirmed metastatic or recurrent gastric cancer
- with at least one measurable lesion by RECIST criteria
- an age of ≥ 18
- adequate oral intake
- no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without S-1 was allowed if finished 6 months before enrollment)
Key exclusion criteria (7 listed)
- a history of hypersensitivity to S-1 or LV, usage of drugs interacting with S-1
- serious concomitant conditions (severe heart disease, pulmonary fibrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeficiency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.)
- extensive bone metastasis, brain metastasis or meningeal metastasis
- another synchronous cancer
- surgery within 3 weeks before enrollment
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: tegafur/gimeracil/oteracil potassium40~60mg bid，d1~7 q2W | Drug | S-1 plus LV |
| LVAlso: LeucovorinLV is given simultaneously at a fixed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. | Drug | S-1 plus LV |
Primary outcome
Overall Response Rate (ORR)
Time frame: 1 year
The primary endpoint is overall response rate,which equals the rate of patients with CR+PR.
5 secondary outcomes
Progression free survival (PFS)
Time frame: 1-1.5 years
Overall survival (OS)
Time frame: 1-2.5 years
Time to treatment failure (TTF)
Time frame: 1 year
Disease control rate
Time frame: 1 year
Adverse Events (AEs)
Time frame: 2 year
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 18 Mar 2014.
- Background: PubMed 19828562Koizumi W, Boku N, Yamaguchi K, Miyata Y, Sawaki A, Kato T, Toh Y, Hyodo I, Nishina T, Furuhata T, Miyashita K, Okada Y. Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer. Ann Oncol. 2010 Apr;21(4):766-771. doi: 10.1093/annonc/mdp371. Epub 2009 Oct 14.
- Derived from this study: PubMed 27913881He MM, Zhang DS, Wang F, Wang ZX, Yuan SQ, Wang ZQ, Luo HY, Ren C, Qiu MZ, Jin Y, Wang DS, Chen DL, Zeng ZL, Li YH, He YY, Hao YT, Guo P, Wang FH, Zeng YX, Xu RH. Phase II trial of S-1 plus leucovorin in patients with advanced gastric cancer and clinical prediction by S-1 pharmacogenetic pathway. Cancer Chemother Pharmacol. 2017 Jan;79(1):69-79. doi: 10.1007/s00280-016-3209-1. Epub 2016 Dec 2.
- Long-term outcomes and prognostic factors of patients with advanced gastric cancer treated with S-1 plus cisplatin combination chemotherapy as a first-line treatment.Link provided by the sponsor.
- S-1-Based Chemotherapy versus Capecitabine-Based Chemotherapy as First-Line Treatment for Advanced Gastric Carcinoma: A Meta-Analysis.Link provided by the sponsor.
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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.
Ruihua Xu, Professor principal investigator
SunYat-sen University Cancer Center
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 and LV in people with Gastric Cancer, run by Sun Yat-sen University at 1 site in China.
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 7 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 18 Mar 2014. 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 China. 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?
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 Response Rate (ORR) (time frame: 1 year). 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 NCT02090153, 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 18 Mar 2014.