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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009144
Receipt No. 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

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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
Email 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
Email yasushis@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine Dept. of Internal Medicine(4)
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010718

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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