UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007142 |
|---|---|
| Receipt number | 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 22:40:02 |
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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
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
Sponsor or person
Institute
Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008411
