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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
N/A
Open (Enrolling)
Both
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
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

Type of Study:

Interventional

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:

No

Principal Investigator

Jin Li, MD,PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University

Authority:

China: Ethics Committee

Study ID:

SL-eCRC

NCT ID:

NCT01193452

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

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