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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015620
Receipt No. R000018151
Scientific Title Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer
Date of disclosure of the study information 2014/11/07
Last modified on 2018/05/14

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Basic information
Public title Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer
Acronym Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer
Scientific Title Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer
Scientific Title:Acronym Phase I study of FOLFOXIRI+cetuximab in patients with RAS wild-type unresectable colorectal cancer
Region
Japan

Condition
Condition RAS wild-type unresectable colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine maximaum tolerated dose and recommended dose of FOLFOXIRI+cetuximab.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Recommended dose
Key secondary outcomes Response rate
Safety

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 FOLFOXIRI+cetuximab (until 12 courses)
Cetuximab 400mg/m2/weekly (initial dose)
250mg/m2/weekly (maintenance)
Irinotecan 100-150mg/m2/bi-weekly
Oxaliplatin 85mg/m2/bi-weekly
5-FU 2400mg/m2/bi-weekly
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) Measurable lesion by RECIST ver.1.1.
3) ECOG performance status 0-1.
4) No prior chemotherapy for unresectable disease.
5) RAS wild-type.
6) Life expectancy of more than 12 weeks.
7) Written informed consent.
8) Age; more than 20 years old and less than 75 years old.
Key exclusion criteria 1) Symptomatic brain metastasis.
2) Diarrhea greater than Grade 2.
3) Paralytic or mechanical bowel obstruction.
4) Confirmed orsuspected active infection.
5) Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema).
6) Serious complications (uncontrolled diabetes, heart failure with NYHA 3 or 4, renal failure, liver failure).
7) Coronary heart disease or myocardial infarction within 12 months prior to the registration.
8) Women who are pregnant or breastfeeding. Patients who are unwilling to avoid pregnancy.
9) Carcinomatous meningitis, uncontrolled convulsive attack, mental disorders, or clinically important CNS diseases.
10) Peripheral neuropathy greater than Grade 2.
11) UGT1A1*6/*6, UGT1A1*28/*28, or UGT1A1*6/*28.
12) Administration of phenytoin, warfarin, or atazanavir sulfate.
13) History of severe drug-induced hypersensitivity syndrome.
14) History of hypersensitivity greater than Grade 2 after FOLFOX therapy.
15) Prior anti-EGFR antibodies.
16) Unrecoverd from surgey within 4 weeks prior to the registration.
17) Radiotherapy within 4 weeks prior to the registration.
18) massive pleural, abdominal, or cardiac effusion.
19) HBs-Ag(+), HCV-Ab(+), or HIV-Ab(+).
20) Active multiple malignancy.
21) Any other cases who are regarded as inadequate for study enrollment by investigators.
Target sample size 12

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kei Muro
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan
TEL 052-762-6111
Email kmuro@aichi-cc.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Shigenori Kadowaki
Organization Aichi Cancer Center Hospital
Division name Department of Clinical Oncology
Zip code
Address 1-1 Kanokoden, Chikusa-ku, Nagoya 464-8681, Aichi, Japan
TEL 052-762-6111
Homepage URL
Email skadowaki@aichi-cc.jp

Sponsor
Institute Aichi Cancer Center Hospital
Institute
Department

Funding Source
Organization Aichi Cancer Center Hospital
Organization
Division
Category of Funding Organization Other
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 愛知県がんセンター中央病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 07 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
2014 Year 11 Month 06 Day
Last modified on
2018 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018151

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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