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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007142
Receipt No. R000008411
Scientific Title Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.
Date of disclosure of the study information 2012/01/26
Last modified on 2015/01/09

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Basic information
Public title Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.
Acronym Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.
Scientific Title Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.
Scientific Title:Acronym Phase II study of TS-1 and CPT-11 combination chemotherapy in patients with advanced/recurrent colorectal cancer.
Region
Japan

Condition
Condition advanced/recurrent colorectal cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical effectiveness and toxicity of Irinotecan and TS-1 combination chemotherapy for advanced/recurrent colorectal cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes overall survival, frequency and grade of adverse 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 CPT-11 80 mg/m2 is administered with 90 min intravenous injection on days 1, 15 repeated every 5 weeks.
TS-1 80 mg/m2/day is administered orally for 3 consecutive weeks every 5 weeks.
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
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Histopathological confirmation of Adenocarcinoma
2) Patients with confirmed target lesion
3) Patient with/without prior chemotherapy.
4) Age of 20~75
5) ECOG performance status of 0 to 1
6) Expected more than 3 months survival
7) Sufficient function of important organs
1.WBC:4,000~12,000 /mm3
2.Neu : >= 2,000 /mm3
3.Platelet : >= 100,000 /mm3
4.hemoglobin : >= 9.0 g/dL
5.AST, ALT : < ULNx2.5 IU/L
6.Sr.bil : < 1.5 mg/dL
7.Serum creati : <= ULN
8.Ccr : >= 50 ml/min
8) With written informed consent
9) Sufficient oral intake
Key exclusion criteria 1) Interstitial pneumoni, fibroid lung
2) Massive pleural or abdominal effusion
3) Patients with active synchronous or metachronous malignancy other than carcinoma in situ
4) Infection, intestinal paralysis / enterostasis
5) Watery stools or diarrhea
6) Uncontrolled diabetes mellitus
7) Severe complications
8) Metastasis to CNS
9) Pregnant or lactating woman
10) History of the severe hypersensitivity
11) Systemic administration of corticosteroids
12) Other patients who are unfit for the study as determined by the attending physician.
Target sample size 55

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mutumi Fukunaga
Organization Sakai Municipal Hospital
Division name Department of Surgery, Gastroenterological Surgery
Zip code
Address 1-1-1, Minamiyasuicho, Sakai-ku, Sakai 590-0064
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Division name Department of GI Surgery
Zip code
Address 2-2-E2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL 06-6879-3251
Homepage URL
Email

Sponsor
Institute Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 26 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 Completed
Date of protocol fixation
2004 Year 06 Month 02 Day
Date of IRB
Anticipated trial start date
2004 Year 06 Month 01 Day
Last follow-up date
2008 Year 05 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 26 Day
Last modified on
2015 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008411

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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