Feasibility Study of SOL (S-1,Oral Leucovorin,and Oxaliplatin) for Colorectal Cancer in China (SCI-101)
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ClinicalTrials.gov Identifier: NCT01110941 |
Recruitment Status
:
Completed
First Posted
: April 27, 2010
Last Update Posted
: May 19, 2015
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Drug: S-1, leucovorin, oxaliplatin | Phase 1 Phase 2 |
- Endpoints:
- Primary endpoints: adverse drug reaction
-
Secondary endpoints:
- Overall Response Rate:ORR
- Progress Free Survival: PFS
- Time to Treatment Failure:TTF
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multicenter Feasibility Study With S-1, Oxaliplatin and Oral Leucovorin (SOL) for the Patients With Untreated Metastatic Colorectal Cancer |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | March 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: SOL
single arm
|
Drug: S-1, leucovorin, oxaliplatin
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.
Other Names:
|
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: from first administration till 28 days after last dosage ]
- 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) [ Time Frame: every 6 weeks ]

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Ages Eligible for Study: | 20 Years to 80 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01110941
China, Beijing | |
Beijing Cancer Hospital | |
Beijing, Beijing, China, 100036 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Shen Lin, pro, Peking University |
ClinicalTrials.gov Identifier: | NCT01110941 History of Changes |
Other Study ID Numbers: |
SOL feasibility study |
First Posted: | April 27, 2010 Key Record Dates |
Last Update Posted: | May 19, 2015 |
Last Verified: | May 2015 |
Keywords provided by Shen Lin, Peking University:
S-1 leucovorin oxaliplatin |
colorectal cancer SOL unresectable or recurrent colorectal cancer |
Additional relevant MeSH terms:
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases |
Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Oxaliplatin Antineoplastic Agents |