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A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

Phase 2
65 Years
Open (Enrolling)
Colorectal Cancer

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Trial Information

A Randomized Phase II Study of Comparing S-1/Leucovorin With sLV5FU2 as the First-line Treatment for Elderly Patients With Colorectal Cancer

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.

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

response rate

Outcome Time Frame:

six weeks

Safety Issue:


Principal Investigator

Jin Li, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Ethics Committee

Study ID:




Start Date:

August 2010

Completion Date:

February 2012

Related Keywords:

  • Colorectal Cancer
  • elderly patients
  • advanced colorectal cancer
  • chemotherapy
  • S-1
  • 5-fluorouracil
  • leucovorin
  • Colorectal Neoplasms