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

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01193452

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

5.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Drug: S-1, Leucovorin Drug: leucovorin, 5-fluorouracil	Phase 2

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2010

Anticipated Primary Completion Date :

Feb 1, 2011

Anticipated Study Completion Date :

Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: S-1/LV S-1 combined with Leucovorin	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 Leucovorin: 25mg twice per day po. The treatment is given for one week,and no chemotherapy is given for the following one week. Other Names: chemotherapy
Active Comparator: sLV5FU2 5-FU/LV infusion	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 Names: chemotherapy

Arm

Intervention/Treatment

Experimental: S-1/LV

S-1 combined with Leucovorin

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 Leucovorin: 25mg twice per day po. The treatment is given for one week,and no chemotherapy is given for the following one week.

Other Names:

chemotherapy

Active Comparator: sLV5FU2

5-FU/LV infusion

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 Names:

chemotherapy

Outcome Measures

Primary Outcome Measures

response rate [six weeks]

Secondary Outcome Measures

progression free survival [six weeks]
disease control rate [six weeks]
time to treatment failure [six weeks]
overall survival [three months]
quality of life [six weeks]
Number of Participants with Adverse Events as a Measure of Safety and Tolerability [six weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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