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S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01193452
Recruitment Status : Unknown
Verified August 2010 by Fudan University.
Recruitment status was:  Recruiting
First Posted : September 2, 2010
Last Update Posted : September 2, 2010
Information provided by:
Fudan University

Tracking Information
First Submitted Date  ICMJE August 31, 2010
First Posted Date  ICMJE September 2, 2010
Last Update Posted Date September 2, 2010
Study Start Date  ICMJE August 2010
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 1, 2010)
response rate [ Time Frame: six weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2010)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
Official Title  ICMJE A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: S-1, Leucovorin

    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


    25mg twice per day po.

    The treatment is given for one week,and no chemotherapy is given for the following one week.

    Other Name: chemotherapy
  • Drug: leucovorin, 5-fluorouracil

    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

    Other Name: chemotherapy
Study Arms  ICMJE
  • Experimental: S-1/LV
    S-1 combined with Leucovorin
    Intervention: Drug: S-1, Leucovorin
  • Active Comparator: sLV5FU2
    5-FU/LV infusion
    Intervention: Drug: leucovorin, 5-fluorouracil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 1, 2010)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2012
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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
  • The lab values within 2 weeks prior to trial should meet:

PLT ≥7.5*10^4/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

Exclusion Criteria:

  • 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
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01193452
Other Study ID Numbers  ICMJE SL-eCRC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jin Li, Fudan University Shanghai Cancer Center
Study Sponsor  ICMJE Fudan University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin Li, MD,PhD Fudan University
PRS Account Fudan University
Verification Date August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP