CompletedPhase 1/2

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

China20 participantsStarted 2009-09

Plain-language summary

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.

Who can participate

Age range

20 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Timeframe: from first administration till 28 days after last dosage

Trial details

NCT IDNCT01110941

SponsorShen Lin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-03

View on ClinicalTrials.gov More Colorectal Cancer trials