UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009144 |
|---|---|
| Receipt number | R000010718 |
| Scientific Title | Phase I/II study of XELOXIRI(CPT-11,L-OHP, capecitabine) with Cetuximab in patients with kras wild type-unresectable advanced/metastatic colorectal cancer |
| Date of disclosure of the study information | 2012/10/18 |
| Last modified on | 2014/05/13 12:05:19 |
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Basic information
Public title
Phase I/II study of XELOXIRI(CPT-11,L-OHP, capecitabine) with Cetuximab
in patients with kras wild type-unresectable advanced/metastatic colorectal cancer
Acronym
XELOXIRI+Cetuximab
Scientific Title
Phase I/II study of XELOXIRI(CPT-11,L-OHP, capecitabine) with Cetuximab
in patients with kras wild type-unresectable advanced/metastatic colorectal cancer
Scientific Title:Acronym
XELOXIRI+Cetuximab
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the recommended dose of Cetuximab with XELOXIRI as 1st line treatment in patients of metastatic colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
recommended dose
Safety
Key secondary outcomes
Response 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
Patients receive infusional CPT-11,L-OHP, Cetuximab, and oral capecitabine every 21 days.
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)Histologically confirmed colorectal cancer.
2)Clinically proven unresectable advanced/
metastatic colorectal cancer
3) 20 to 74 years of age
4) ECOG performance status 0-1
5) Presence of measurable lesion
6) No previous history of chemotherapy or radiotherapy for unresectable advanced/
metastatic colorectal cancer
8) Adequate organ functions
9) Estimated life expectancy 3 months
10) Written informed consent
11) kras wild status
Key exclusion criteria
1)Prior severe drug allergy.
2) Synchronous and/or metachronous multiple cancers.
3) Prior chemotherapy with CPT-11,L-OHP, capecitabeine or Cetuximab containing regimen.
4)Surgical procedure within 28 days prior to enrollment.
5) Severe comorbidity
- Severe pulmonary dysfunction
- Uncontrolled DM
- Uncontrolled HT
- Severe cardiovascular disease
- Cirrhosis and liver failure
- Renal failure
6) Sensory neuropathy
7) Severe diarrhea
8) Active infection
9) Symptomatic pleural effusion or ascites
10)Contraindications to CPT-11, L-OHP, capecitabeine or Cetuximab
11) Concerning pregnancy
12) The investigator considers not suitable for the study.
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Sapporo Medical University School of Medicine
Division name
Dept. of Internal Medicine(4)
Zip code
Address
S1W17, Chuo-ku, Sapporo, Japan
TEL
0116112111
yasushis@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Sapporo Medical University School of Medicine
Division name
Dept. of Internal Medicine(4)
Zip code
Address
S1W17, Chuo-ku, Sapporo, Japan
TEL
0116112111
Homepage URL
yasushis@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)
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 | 10 | Month | 18 | 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
| 2012 | Year | 06 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 18 | Day |
Last modified on
| 2014 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010718
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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