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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000002308
Receipt No. R000002818
Scientific Title 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.
Date of disclosure of the study information 2009/08/07
Last modified on 2012/12/07

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Basic information
Public title 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.
Acronym 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.
Scientific Title 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.
Scientific Title:Acronym 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.
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate for safety and efficacy 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 objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Disease control rate
Key secondary outcomes Response rate, Progression free survival, Overall survival, frequency of adverese event

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 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.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 20 years to 80
ECOG PS of 0, 1, or 2
Patients who are treated containing irinotecan and oxaliplatin regimes for unresectable or recurrent colorectal cancer.
Able to take capsules orally.
Adequate function of major organs as defined below:
White blood cell count >3,500/mm3, <12,000/mm3
Neutrophil count >1,500/mm3
Hemoglobin >9.0 g/dL
Platelet count >100,000/mm3
Total bilirubin <1.5 mg/dL
AST and ALT <100 U/L (<200 U/L in patients with liver metastasis)
Serum creatinine <1.2 mg/dL
Creatinine clearance estimate by the Cockcroft-Gault method >50 mL/min
Urine dipstick for proteinuria should be <1+
INR<1.5
Voluntary written informed consent.
Key exclusion criteria Active 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.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroya Takiuchi
Organization Osaka Medical College Hospital
Division name Cancer Chemotherapy Center
Zip code
Address 2-7 Daigakumachi, Takatsuki, Osaka, Japan 569-8686
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Motoki Yoshida
Organization Osaka Medical College Hospital
Division name Cancer Chemotherapy Center
Zip code
Address 2-7 Daigakumachi, Takatsuki, Osaka, Japan 569-8686
TEL 072-683-1221
Homepage URL
Email ctc004@poh.osaka-med.ac.jp

Sponsor
Institute Translational Research Informatics Center(TRI)
Institute
Department

Funding Source
Organization Taiho Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs YES
Study ID_1 TRICC0901
Org. issuing International ID_1 PDQ
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2009 Year 06 Month 29 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 06 Month 01 Day
Date of closure to data entry
2012 Year 07 Month 01 Day
Date trial data considered complete
2012 Year 07 Month 01 Day
Date analysis concluded
2012 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 07 Day
Last modified on
2012 Year 12 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002818

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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