NIPH Clinical Trials Search

UMIN ID: UMIN000002308

Registered date:07/08/2009

Phase II study of combination chemotherapy with S-1 plus Avastin in unresectable or recurrent colorectal cancer after failure of prior chemotherapy, including irinotecan and oxaliplatin regimens.

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedcolorectal cancer
Date of first enrollment2009/07/01
Target sample size40
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)A phase II study of third-line and subsequent treatment with S-1 alone performed in Korea in patients with unresectable, advanced or recurrent colorectal cancer reported a disease control rate of 42.9% (95% confidence interval, 23.3% to 62.4%). Because bevacizumab was combined with S-1 in the present study, a higher disease control rate is expected. The threshold rate was therefore set at 30% and the expected rate at 50%. Using Fleming's single-stage procedure, we estimated that 35 patients would be required for the study to have a statistical power (1- ) of 0.80 or higher with a one-sided  value of 0.05. We assumed that more than 10% of enrolled patients would drop out of the study. The target number of enrolled patients was therefore set at 40.


Primary OutcomeDisease control rate
Secondary OutcomeResponse rate, Progression free survival, Overall survival, frequency of adverese event

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum80years-old
GenderMale and Female
Include criteria
Exclude criteriaActive infections (e.g., patients with pyrexia of 38'C or higher) Continuous treatment with steroids Serious complications (e.g., pulmonary fibrosis, interstitial pneumonitis, heart failure, renal failure, hepatic failure, or poorly controlled diabetes and hypertension) Patients with electrocardiographic abnormalities, with cardiac disorder that would clinically preclude the execution of the study judged by the investigator. Moderate or severe ascites or pleural effusion requiring treatment Active double cancer prior therapy radiotherapy prior therapy S-1 Pregnant women, possibly pregnant women, women wishing to become pregnant, and nursing mothers. Men who are currently attempting to conceive children. Serious drug hypersensitivity or a history of drug allergy Treatment with flucytosine Metastasis to the CNS Thrombosis, cerebral infarction, myocardial infarction, or pulmonary embolism History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding (Patients who treated low aspirin therapy(<325 mg/day) can be enrolled.) Major surgical procedure, open biopsy, or clinically significant traumatic injury within 4 weeks Severe mental disorder Judged ineligible for participation in the study by the investigator for safety reasons.

Related Information


public contact
Name Motoki Yoshida
Address 2-7 Daigakumachi, Takatsuki, Osaka, Japan 569-8686 Japan
Telephone 072-683-1221
Affiliation Osaka Medical College Hospital Cancer Chemotherapy Center
scientific contact
Name Hiroya Takiuchi
Address 2-7 Daigakumachi, Takatsuki, Osaka, Japan 569-8686 Japan
Affiliation Osaka Medical College Hospital Cancer Chemotherapy Center