Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China

Study Overview
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Brief Summary
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S-1 is an oral fluoropyrimidine with demonstrated efficacy on gastric cancer and colorectal cancer. The new regimen with Oxaliplatin and leucovorin is expected to achieve more encouraging efficacy on colorectal cancer. This study is to explore the feasibility of the SOL regimen on efficacy and tolerability on Chinese colorectal cancer patients.

Detailed Description
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Endpoints: Primary endpoints: adverse drug reaction Secondary endpoints: Overall Response Rate：ORR Progress Free Survival: PFS Time to Treatment Failure：TTF

Official Title
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A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: S-1, leucovorin, oxaliplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Advanced unresectable or recurrent colorectal cancer patients which meet the following criteria: Willing to sign ICF Could orally take investigational product Pathology diagnosis is adenocarcinoma Above 20 years No previous treatment(including: radiotherapy,chemotherapy and immunotherapy) For recurrent cases, if the patient had received adjuvant chemotherapy that didn't include S-1 and L-OHP in 180 days ago, he/she could be enrolled in With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days Lab test within 15 days meet following criteria Hemoglobin higher than 9.0g/dL Leukocyte higher than 12,000/mm3 Neutrophil higher than 2,000/mm3 PLT higher than 10.0 104/mm3 Bilirubin lower than 1.5 times of upper limit of normal range AST,ALT,ALP lower than 2.5 times of upper limit of normal range Creatinine lower than upper limit of normal range When patient has liver metastasis or bone metastasis, the value of AST,ALT,ALP could be within 5 times of upper limit of normal range ECOG 0 or 1 Expected survival time more than 90 days Exclusion Criteria: The patient who meet the following criteria should be excluded from this trial Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist) Attended other clinical trial within 4 weeks Received transfusion of blood,related products or G-CSF within 15 days Received surgery within 4 weeks and the effect hadn't vanished Have diarrhea Have complication of active infection(infection caused fever higher than 38℃) Have complication of poor controlled hypercalcemia,hypertension,diabetes Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina) Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema) Have complication of psychiatric disorder which will affect clinical treatment or have history of CNS disease Have complication of active gastrointestinal bleeding Have pleural effusion,ascites or pericardial effusion that need drainage Have complication of multiple bone metastasis Have severe complication(including:ileus,renal insufficiency,hepatic insufficiency,cerebrovascular disturbance) Have brain metastasis or suspicious brain metastasis Have active multiple primary cancer Female patients who are in pregnancy or lactation and patients who are not willing to take contraception measures Investigator judge not eligible to this trial

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SOL<br>single arm | Drug: S-1, leucovorin, oxaliplatin<br>* S-1(20mg、25mg), capsule, 40 60mg, Bid,p.o., day1 7； LV (25 mg), tablet, 25mg,Bid,p.o., day1 7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.<br>* Other names: L-OHP (50 mg)--Sanofi Aventis Co., Ltd.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | from first administration till 28 days after last dosage | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria, and follow up till disease progression or withdrawal from study due to intolerable adverse events (AE) |  | every 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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S-1, leucovorin, oxaliplatin, colorectal cancer, SOL, unresectable or recurrent colorectal cancer