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

NCT01193452 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2010-09-02

No results posted yet for this study

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.

Conditions

Interventions

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.

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

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Jin Li, MD,PhD · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-02-28
Completion
2012-02-29

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01193452 on ClinicalTrials.gov