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

Phase 1/Phase 2
20 Years
80 Years
Open (Enrolling)
Colorectal Cancer

Thank you

Trial Information

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

- Endpoints:

- Primary endpoints: adverse drug reaction

- Secondary endpoints:

- Overall Response Rate:ORR

- Progress Free Survival: PFS

- Time to Treatment Failure:TTF

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

from first administration till 28 days after last dosage

Safety Issue:



China: Food and Drug Administration

Study ID:

SOL feasibility study



Start Date:

September 2009

Completion Date:

October 2010

Related Keywords:

  • Colorectal Cancer
  • S-1
  • leucovorin
  • oxaliplatin
  • colorectal cancer
  • SOL
  • unresectable or recurrent colorectal cancer
  • Colorectal Neoplasms