Colorectal Cancer
Conditions
Brief summary
This is a multicenter study designed to evaluate the response rate of S-1 plus Leucovorin (1 week on and 1 week off) as first -line treatment for patients with metastatic colorectal cancer.
Interventions
DRUGS-1 plus LV (The combination therapy of S-1 and Leucovorin)
S-1 40-60 mg bid day 1～day 7 LV 25 mg bid day 1～day 7
Sponsors
Taiho Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically proved adenocarcinoma * Unresectable and recurrent colorectal cancer * Age20 ≤ at enrollment * Performance status 0 or 1 (ECOG) * No prior treatment (ex. radiation therapy, chemotherapy, hormonal therapy) to advanced disease. Patients who received adjuvant chemotherapy more than 180 days before enrollment can be allowed but those who received S-1 containing treatment shall be excluded * Adequate hematologic, hepatic and renal functions * At least one measurable lesion by RECIST criteria
Exclusion criteria
* Serious drug hypersensitivity * Pregnant or nursing * Bleeding from gastrointestinal tract * Diarrhea * Simultaneously active double cancer * Serious illness or medical condition * Brain metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate (ORR) | During chemotherapy |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | During chemotherapy |
| Safety | During chemotherapy |
| Progression free survival (PFS) | Until progression |
| Feasibility | During chemotherapy |
| Time to treatment failure (TTF) | Until progression |
| Overall survival (OS) | Over two years from registration |
| Disease control rate(DCR) | During chemotherapy |
Countries
China, Japan
Outcome results
None listed