Colorectal CancerPhase 2NCT01193452
S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
A Phase 2 study testing S-1, Leucovorin and leucovorin, 5-fluorouracil in people with Colorectal Cancer, run by Fudan University at 1 site in China.
Trial summary
This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- S-1, Leucovorin and leucovorin, 5-fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Aug 2010to Feb 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Signed written informed consent
- Oral medication is acceptable
- Histologically confirmed colorectal carcinoma
- Male or female ≥ 65 years of age
- No prior chemotherapy,radiotherapy,target therapy and immunotherapy, except adjuvant chemotherapy with an interval of ≥ 180 days)
- Presence of at least one target lesion measurable by CT scan or MRI,within 15 days prior to trial
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- The lab values within 2 weeks prior to trial should meet:
- PLT ≥7.510^4/mm3 ANC≥2000/mm3 HB≥100g/L Total bilirubin < upper limit of normal level ALT/AST/ALP < 2.5 x UNL (<5 x UNL for patients with liver or bone metastasis) Serum creatinine < UNL
- Performance status (ECOG) 0~1
- Life expectation longer than 90 days
Who cannot join
- Allergy to S-1,fluorouracil or leucovorin
- Any investigational agent(s) within 4 weeks prior to entry
- Previous or currently exposure to certain drugs which are proved to have influence on blood drug concentration
- Active infection
- Severe organ failures or diseases, including: intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes mellitus,clinically relevant coronary disease, cardiovascular disorder or myocardial infarction,renal or liver failure, severe psychiatric illness,cerebral vascular disease and sever GI ulcer which need blood infusion.
- Uncontrolled hydrothorax,ascites and hydropericardium
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- Multiple bone metastatic lesions
- Brain metastases
- Chronic diarrhea or digestive disfunction
- Previous malignancy (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
- Strong willingness to receive surgery or highly potential to have intestinal obstruction which may need surgery intervention
- Other conditions that primary investigate or investigator consider to be unsuitable for the trial
Trial locations and contacts
1 site in 1 country.
Jin Li, MD,PhD contact
China1 site, 1 recruiting
- Recruiting
Jin Li'
Shanghai, Shanghai Municipality, 200032
Jin Li, MD,PhD, 8621 64175590 ext. 5100
Wenhua Li, MS, 862164175590 ext. 8900, whliiris@hotmail.com
About this study
Official title: A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.
Read the detailed description
This is a randomized phase Ⅱ study, in which S-1 is used in combination with leucovorin in elderly patients with advanced colorectal cancer as first-line treatment,comparing with sLV5FU2 therapy. The aim of this study is to determine the efficacy and safety of S-1/LV in elderly patients in the first-line setting. The other secondary endpoints are progression free survival,overall survival, and quality of life are also evaluated.
- Conditions
- Colorectal Cancer
- Being tested
- S-1, Leucovorin, leucovorin, 5-fluorouracil
- Keywords
- elderly patients, advanced colorectal cancer, chemotherapy, S-1, 5-fluorouracil, 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, LeucovorinDrug
Also called chemotherapy
S-1 :
The initial dosage of S-1 is determined by the body surface area:
Surface area: 1.25-1.5 m2 : 50mg twice per day;upper than 1.5 m2 : 60mg twice per day
Leucovorin:
25mg twice per day po.
The treatment is given for one week,and no chemotherapy is given for the following one week.
leucovorin, 5-fluorouracilDrug
Also called chemotherapy
leucovorin: 400mg/m2 intravenous infusion d1;
5-fluorouracil: 400mg/m2 intravenous push,d1; 2400mg/m2 continuous intravenous infusion for 46 hours
repeat every 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| S-1/LV | Experimental | S-1 combined with Leucovorin Receives: Drug: S-1, Leucovorin |
| sLV5FU2 | Active comparator | 5-FU/LV infusion Receives: Drug: leucovorin, 5-fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: six weeks
Secondary outcomes (6)
progression free survival
Measured: six weeks
disease control rate
Measured: six weeks
time to treatment failure
Measured: six weeks
overall survival
Measured: three months
quality of life
Measured: six weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2012 (estimated)
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.
- More trials run by Fudan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Investigators
- Jin Li, MD,PhD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193452
- Sponsor's protocol ID
- SL-eCRC
- Status last verified
- Aug 2010
- First submitted
- 31 Aug 2010
- Last updated
- 2 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT01193452
- Acronym / sponsor ID
- SL-eCRC
- Conditions
- Colorectal Cancer
- Keywords
- elderly patients, advanced colorectal cancer, chemotherapy, S-1, 5-fluorouracil, leucovorin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 2 Sep 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.
This phase II trial on the assumption that S-1 combined with Leucovorin may have better efficacy and safety than simplified 5-FU/LV infusion therapy in elderly patients with advanced colorectal cancer.
Detailed description
This is a randomized phase Ⅱ study, in which S-1 is used in combination with leucovorin in elderly patients with advanced colorectal cancer as first-line treatment,comparing with sLV5FU2 therapy. The aim of this study is to determine the efficacy and safety of S-1/LV in elderly patients in the first-line setting. The other secondary endpoints are progression free survival,overall survival, and quality of life are also evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| S-1/LV | Experimental | Drug: S-1, LeucovorinS-1 combined with Leucovorin |
| sLV5FU2 | Active comparator | Drug: leucovorin, 5-fluorouracil5-FU/LV infusion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- Signed written informed consent
- Oral medication is acceptable
- Histologically confirmed colorectal carcinoma
- Male or female ≥ 65 years of age
- No prior chemotherapy,radiotherapy,target therapy and immunotherapy, except adjuvant chemotherapy with an interval of ≥ 180 days)
Key exclusion criteria (12 listed)
- Allergy to S-1,fluorouracil or leucovorin
- Any investigational agent(s) within 4 weeks prior to entry
- Previous or currently exposure to certain drugs which are proved to have influence on blood drug concentration
- Active infection
- Severe organ failures or diseases, including: intestinal obstruction, pulmonary fibrosis, uncontrolled diabetes mellitus,clinically relevant coronary disease, cardiovascular disorder or myocardial infarction,renal or liver failure, severe psychiatric illness,cerebral vascular disease and sever GI ulcer which need blood infusion.
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, LeucovorinAlso: chemotherapyS-1 : The initial dosage of S-1 is determined by the body surface area: Surface area: 1.25-1.5 m2 : 50mg twice per day;upper than 1.5 m2 : 60mg twice per day Leucovorin: 25mg twice per day po. The treatment is given for one week,and no chemotherapy is given for the following one week. | Drug | S-1/LV |
| leucovorin, 5-fluorouracilAlso: chemotherapyleucovorin: 400mg/m2 intravenous infusion d1; 5-fluorouracil: 400mg/m2 intravenous push,d1; 2400mg/m2 continuous intravenous infusion for 46 hours repeat every 2 weeks | Drug | sLV5FU2 |
Primary outcome
response rate
Time frame: six weeks
6 secondary outcomes
progression free survival
Time frame: six weeks
disease control rate
Time frame: six weeks
time to treatment failure
Time frame: six weeks
overall survival
Time frame: three months
quality of life
Time frame: six weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: six weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2010.
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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.
Jin Li, MD,PhD contact
Jin Li, MD,PhD principal investigator
Fudan University
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, Leucovorin and leucovorin, 5-fluorouracil in people with Colorectal Cancer, run by Fudan 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 10 inclusion and 12 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 2 Sep 2010. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jin Li, MD,PhD (64175590 ext. 5100), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
response rate (time frame: six weeks). 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 2 Sep 2010.