UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002308 |
|---|---|
| Receipt number | 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 23:28:27 |
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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
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
ctc004@poh.osaka-med.ac.jp
Sponsor or person
Institute
Translational Research Informatics Center(TRI)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002818
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