Colorectal CancerPhase 2NCT00891332
Study of S-1 Plus LV for Untreated Metastatic Colorectal Cancer
A Phase 2 study testing S-1 plus LV (The combination therapy of S-1 and Leucovorin) in people with Colorectal Cancer, run by Taiho Pharmaceutical Co., Ltd. at 6 sites in 2 countries.
Trial summary
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- S-1 plus LV (The combination therapy of S-1 and Leucovorin)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Oct 2008to Nov 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proved adenocarcinoma
- Unresectable and recurrent colorectal cancer
- Age20 ≤ at enrollment
- Performance status 0 or 1 (ECOG)
- No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
- Adequate hematologic, hepatic and renal functions
- At least one measurable lesion by RECIST criteria
Who cannot join
- Serious drug hypersensitivity
- Pregnant or nursing
- Bleeding from gastrointestinal tract
- Diarrhea
- Simultaneously active double cancer
- Serious illness or medical condition
- Brain metastasis
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
China5 sites
Shanghai Fudan University Cancer Hospital, Division of Oncology
Dong An Road, Shanghai, 200032
Sun Yat-sen University Cancer Center, Division of Oncology
Dong Feng Dong road,Guangzhou, Guangdong, 510060
PLA 307 Hospital, No.4 Division of Oncology
East Avenue, Fengtai District, Beijing, 100071
Beijing Cancer Hospital, Digestive System Medicine Department
Fucheng Road, Haidian District, Beijing, 100036
Cancer Institute & Hospital Chinese Academy of Medical Sciences, Division of Oncology
Panjiayuan Nanli, Chaoyang District, Beijing, 100021
Japan1 site
Graduate School of Medical Sciences Kumamoto University
1-1-1, Honjo Kumamoto-city, Kumamoto, 860-8556
About this study
Official title: Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.
- Conditions
- Colorectal Cancer
- Being tested
- S-1 plus LV (The combination therapy of S-1 and Leucovorin)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-1 plus LV (The combination therapy of S-1 and Leucovorin)Drug
S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | S-1 plus LV Receives: Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: During chemotherapy
Secondary outcomes (7)
Safety
Measured: During chemotherapy
Progression free survival (PFS)
Measured: Until progression
Disease control rate(DCR)
Measured: During chemotherapy
Time to treatment failure (TTF)
Measured: Until progression
Overall survival (OS)
Measured: Over two years from registration
Feasibility
Measured: During chemotherapy
Pharmacokinetics
Measured: During chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2009 (estimated)
- Study startOct 2008
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hideo Baba, M.D., Principal investigator, Graduate School of Medical Sciences Kumamoto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891332
- Sponsor's protocol ID
- Taiho10020400
- Status last verified
- Jan 2012
- First submitted
- 30 Apr 2009
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of S-1 Plus LV (1 Week on and 1 Week Off) as First-line Treatment for Patients With Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT00891332
- Acronym / sponsor ID
- Taiho10020400
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Taiho Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 May 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.
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: S-1 plus LV (The combination therapy of S-1 and Leucovorin)S-1 plus LV |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically proved adenocarcinoma
- Unresectable and recurrent colorectal cancer
- Age20 ≤ at enrollment
- Performance status 0 or 1 (ECOG)
- No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded
Key exclusion criteria (7 listed)
- Serious drug hypersensitivity
- Pregnant or nursing
- Bleeding from gastrointestinal tract
- Diarrhea
- Simultaneously active double 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-1 plus LV (The combination therapy of S-1 and Leucovorin)S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7 | Drug | 1 |
Primary outcome
Overall Response Rate (ORR)
Time frame: During chemotherapy
7 secondary outcomes
Safety
Time frame: During chemotherapy
Progression free survival (PFS)
Time frame: Until progression
Disease control rate(DCR)
Time frame: During chemotherapy
Time to treatment failure (TTF)
Time frame: Until progression
Overall survival (OS)
Time frame: Over two years from registration
Feasibility
Time frame: During chemotherapy
Pharmacokinetics
Time frame: During chemotherapy
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 Jan 2012.
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Hideo Baba, M.D. principal investigator
Graduate School of Medical Sciences Kumamoto University
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing S-1 plus LV (The combination therapy of S-1 and Leucovorin) in people with Colorectal Cancer, run by Taiho Pharmaceutical Co., Ltd. at 6 sites in 2 countries.
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 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 6 sites in China, 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 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: 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 18 Jan 2012.