Back to resultsS-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
S-1, Leucovorin
leucovorin, 5-fluorouracil
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring elderly patients, advanced colorectal cancer, chemotherapy, S-1, 5-fluorouracil, leucovorin
Eligibility Criteria
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
Sites / Locations
- Jin Li'Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
S-1/LV
sLV5FU2
Arm Description
S-1 combined with Leucovorin
5-FU/LV infusion
Outcomes
Primary Outcome Measures
response rate
Secondary Outcome Measures
progression free survival
disease control rate
time to treatment failure
overall survival
quality of life
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01193452
Brief Title
S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2010 (undefined)
Primary Completion Date
February 2011 (Anticipated)
Study Completion Date
February 2012 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
elderly patients, advanced colorectal cancer, chemotherapy, S-1, 5-fluorouracil, leucovorin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
S-1/LV
Arm Type
Experimental
Arm Description
S-1 combined with Leucovorin
Arm Title
sLV5FU2
Arm Type
Active Comparator
Arm Description
5-FU/LV infusion
Intervention Type
Drug
Intervention Name(s)
S-1, Leucovorin
Other Intervention Name(s)
chemotherapy
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
leucovorin, 5-fluorouracil
Other Intervention Name(s)
chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
response rate
Time Frame
six weeks
Secondary Outcome Measure Information:
Title
progression free survival
Time Frame
six weeks
Title
disease control rate
Time Frame
six weeks
Title
time to treatment failure
Time Frame
six weeks
Title
overall survival
Time Frame
three months
Title
quality of life
Time Frame
six weeks
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Li, MD,PhD
Phone
64175590
Ext
5100
First Name & Middle Initial & Last Name or Official Title & Degree
Wenhua Li, MS
Phone
64175590
Ext
8900
Email
whliiris@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD,PhD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jin Li'
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin Li, MD,PhD
Phone
8621 64175590
Ext
5100
First Name & Middle Initial & Last Name & Degree
Wenhua Li, MS
Phone
862164175590
Ext
8900
Email
whliiris@hotmail.com
First Name & Middle Initial & Last Name & Degree
Wen Zhang
12. IPD Sharing Statement
Learn more about this trial
S-1/Leucovorin (SL) Versus sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer
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