Clinical trial NCT01193452: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: elderly patients
advanced colorectal cancer
chemotherapy
S-1
5-fluorouracil
leucovorin
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2010-09-02
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: response rate
timeFrame: six weeks
Secondary outcomes:
measure: progression free survival
timeFrame: six weeks
measure: disease control rate
timeFrame: six weeks
measure: time to treatment failure
timeFrame: six weeks
measure: overall survival
timeFrame: three months
measure: quality of life
timeFrame: six weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: six weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Jin Li'
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jin Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: