Colorectal CancerPhase 1/2SCI-101NCT01110941
Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China
A Phase 1/2 study testing S-1, leucovorin, oxaliplatin in people with Colorectal Cancer, run by Shen Lin at 1 site in China.
Trial summary
S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- S-1, leucovorin, oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2009to Oct 2010
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria:
- Willing to sign ICF
- Could orally take investigational product
- Pathology diagnosis is adenocarcinoma
- Above 20 years
- No previous treatment(including: radiotherapy,chemotherapy and immunotherapy)
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- For recurrent cases, if the patient had received adjuvant chemotherapy that didn't include S-1 and L-OHP in 180 days ago, he/she could be enrolled in
- With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days
- Lab test within 15 days meet following criteria
- Hemoglobin higher than 9.0g/dL
- Leukocyte higher than 12,000/mm3
- Neutrophil higher than 2,000/mm3
- PLT higher than 10.0 104/mm3
- Bilirubin lower than 1.5 times of upper limit of normal range
- AST,ALT,ALP lower than 2.5 times of upper limit of normal range
- Creatinine lower than upper limit of normal range
- When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range
- ECOG 0 or 1
- Expected survival time more than 90 days
Who cannot join
- The patient who meet the following criteria should be excluded from this trial
- Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist)
- Attended other clinical trial within 4 weeks
- Received transfusion of blood,related products or G-CSF within 15 days
- Received surgery within 4 weeks and the effect hadn't vanished
- Have diarrhea
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- Have complication of active infection(infection caused fever higher than 38℃)
- Have complication of poor controlled hypercalcemia,hypertension,diabetes
- Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina)
- Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema)
- Have complication of psychiatric disorder which will affect clinical treatment or have history of CNS disease
- Have complication of active gastrointestinal bleeding
- Have pleural effusion,ascites or pericardial effusion that need drainage
- Have complication of multiple bone metastasis
- Have severe complication(including:ileus,renal insufficiency,hepatic insufficiency,cerebrovascular disturbance)
- Have brain metastasis or suspicious brain metastasis
- Have active multiple primary cancer
- Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures
- Investigator judge not eligible to this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer
S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.
Read the detailed description
- Endpoints:
- Primary endpoints: adverse drug reaction
- Secondary endpoints:
- Overall Response Rate：ORR
- Progress Free Survival: PFS
- Time to Treatment Failure：TTF
- Conditions
- Colorectal Cancer
- Being tested
- S-1, leucovorin, oxaliplatin
- Keywords
- S-1, leucovorin, oxaliplatin, colorectal cancer, SOL, unresectable or recurrent colorectal cancer
- 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, leucovorin, oxaliplatinDrug
Also called S-1(20mg、25mg)--Taiho Pharmaceutical Co., Ltd.；, LV (25 mg)；, L-OHP (50 mg)--Sanofi Aventis Co., Ltd.
S-1(20mg、25mg), capsule, 40~60mg, Bid,p.o., day1~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.
| Study group | Role | What they receive |
|---|---|---|
| SOL | Experimental | single arm Receives: Drug: S-1, leucovorin, oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: from first administration till 28 days after last dosage
Secondary outcomes (1)
Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE)
Measured: every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionMar 2010
- Study completionOct 2010
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shen Lin
- Sponsor type
- University, hospital or other
- Collaborators
- 307 Hospital of PLA, Beijing Union Hosptial, Tianjin Medical University Cancer Institute and Hospital, Hebei Provincial Cancer Hospital
- Responsible party
- Sponsor-investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110941
- Sponsor's protocol ID
- SOL feasibility study
- Acronym
- SCI-101
- Status last verified
- May 2015
- First submitted
- 21 Apr 2010
- Last updated
- 19 May 2015
- Results posted
- No
Publications
Lu M, Wang Y, Liu W, Bai C, Xu J, Shen L. A Multicenter Feasibility Study with S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients with Untreated Metastatic Colorectal Cancer: The Result of Final Analysis. Hepatogastroenterology. 2014 Jun;61(132):1018-23.
PubMed 26158159
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01110941
- Acronym / sponsor ID
- SCI-101 / SOL feasibility study
- Conditions
- Colorectal Cancer
- Keywords
- S-1, leucovorin, oxaliplatin, colorectal cancer, SOL, unresectable or recurrent colorectal cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shen LinUniversity, hospital or other
- Collaborators
- 307 Hospital of PLA, Beijing Union Hosptial, Tianjin Medical University Cancer Institute and Hospital, Hebei Provincial Cancer Hospital
- Study start
- Sep 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 27 Apr 2010 (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.
S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.
Detailed description
- Endpoints:
- Primary endpoints: adverse drug reaction
- Secondary endpoints:
- Overall Response Rate：ORR
- Progress Free Survival: PFS
- Time to Treatment Failure：TTF
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SOL | Experimental | Drug: S-1, leucovorin, oxaliplatinsingle arm |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria:
- Lab test within 15 days meet following criteria
- When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range
- ECOG 0 or 1
- Expected survival time more than 90 days
Key exclusion criteria (19 listed)
- The patient who meet the following criteria should be excluded from this trial
- Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist)
- Attended other clinical trial within 4 weeks
- Received transfusion of blood,related products or G-CSF within 15 days
- Received surgery within 4 weeks and the effect hadn't vanished
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, leucovorin, oxaliplatinAlso: S-1(20mg、25mg)--Taiho Pharmaceutical Co., Ltd.；, LV (25 mg)；, L-OHP (50 mg)--Sanofi Aventis Co., Ltd.S-1(20mg、25mg), capsule, 40~60mg, Bid,p.o., day1~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression. | Drug | SOL |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: from first administration till 28 days after last dosage
1 secondary outcome
Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE)
Time frame: every 6 weeks
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 19 May 2015.
- Derived from this study: PubMed 26158159Lu M, Wang Y, Liu W, Bai C, Xu J, Shen L. A Multicenter Feasibility Study with S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients with Untreated Metastatic Colorectal Cancer: The Result of Final Analysis. Hepatogastroenterology. 2014 Jun;61(132):1018-23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing S-1, leucovorin, oxaliplatin in people with Colorectal Cancer, run by Shen Lin 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 19 inclusion and 19 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 19 May 2015. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: from first administration till 28 days after last dosage). 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 NCT01110941, 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 19 May 2015.