Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China (NCT01110941) | Clinical Trial Compass
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 range20 Years – 80 Years
SexALL
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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…
What they're measuring
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Timeframe: from first administration till 28 days after last dosage