UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002602 |
|---|---|
| Receipt number | R000003033 |
| Scientific Title | Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer |
| Date of disclosure of the study information | 2009/10/09 |
| Last modified on | 2010/08/10 21:49:53 |
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Basic information
Public title
Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer
Acronym
Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer
Scientific Title
Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer
Scientific Title:Acronym
Phase I/II trial of combination chemotherapy using TS-1, CPT-11 and cetuximab with radiation in locally advanced rectal cancer
Region
| Japan |
Condition
Condition
Rectal cancer
Classification by specialty
| Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to establish the feasibility and efficacy of preoperative radiotherapy (RT) with TS-1, CPT-11 and cetuximab in patients with locally advanced rectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Dose-limiting toxicities (DLTs)
Complication rate
R0 resection rate
downstaging rate
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
S-1:80mg/m2 day1-14, 22-35
CPT-11:Level 1 100mg/m2, Level 2 125mg/m2, Level 3 150mg/m2 day1, 22
Cetuximab:400mg/m2 day-7, 250mg/m2 day1, 8, 15, 22, 29, 36
Radiation:1.8 Gy of consecutive 5 days, total dose 50.4 Gy
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
T3-T4 low rectal cancer
Wild type K-ras was observed in DNA analysis.
Key exclusion criteria
Patients were excluded if they had prior RT to the pelvic region or previous cytotoxic chemotherapy or if they had other synchronous cancers. Patients suffering from the following conditions were also ineligible: inflammatory bowel disease, malabsorption syndrome, ischemic heart disease, peripheral neuropathy, and psychiatric disorders or psychologic disabilities thought to adversely affect treatment compliance. In addition, pregnant or lactating patients and women with childbearing potential who lacked effective contraception were excluded.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Ota |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
TEL
045-787-2650
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuyoshi Ota |
Organization
Yokohama City University Graduate School of Medicine
Division name
Gastroenterological surgery
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004 Japan
TEL
045-787-2650
Homepage URL
m_ota@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
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
| 2009 | Year | 10 | Month | 09 | 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 | 08 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | 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
| 2009 | Year | 10 | Month | 08 | Day |
Last modified on
| 2010 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003033
