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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010639
Receipt No. R000012444
Scientific Title Phase I study of TS-1+irinotecan+cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Date of disclosure of the study information 2013/05/07
Last modified on 2019/03/08

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Basic information
Public title Phase I study of TS-1+irinotecan+cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Acronym JACCRO CC-10 study
Scientific Title Phase I study of TS-1+irinotecan+cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Scientific Title:Acronym JACCRO CC-10 study
Region
Japan

Condition
Condition metastatic colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determin MTD and RD of TS-1 + irinotecan + cetuximab as the first-line therapy in patients with KRAS wild-type metastatic colorectal cancer
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Recommended Dose
Key secondary outcomes Safety
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 Cetuximab 400mg/m2 Day1, 250mg/m2 Day 8, 15
Irinotecan 100-150mg/m2/Day1
S-1 80-120mg/day Day1-14
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

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients with histologically proven colorectal cancer
(2) KRAS wild type
(3) Presence of evaluable lesion
(4) No prior chmeotherapy or radiotherapy for unresectable primary tumor, metastases and lymphnode metastases. No prior therapy including surgery for reccurent lesions that should be the first relapse after surgery for primary or metastases tumors.
(5) ECOG performance status 0-1
(6) Age 20 years or older
(7) Life expectancy of 3 yeras or longer
(8) Oral food intake possible
(9) Patients have enough organ function for study treatment within 14 days before enrollment
(10) Written informed consent.
Key exclusion criteria 1) Synchronous multiple malignancy or metachronous multiple malignancy within 5 years disease free interval.
2) Symptomatic brain metastases
3) Severe infectious disease.
4) Comorbidity or history of interstitial lung disease or pulmonary fibrosis.
5) Comorbidity or history of severe heart disease.
6) Sensory alteration or paresthesia interfering with function.
7) Large quantity of pleural, abdominal or cardiac effusion.
8) Severe comorbidity (renal failure, liver failure, hypertension, etc.)
9) Prior radiotherapy for primary or metastases tumors.
10) Men/Women who are unwilling to avoid pregnancy. Women who are pregnant or breastfeeding. Women with a positive pregnancy test.
11) Any other cases who are regarded as inadequate for sydy enrollment by investigators.
Target sample size 16

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wataru Ichikawa
Organization National Defense Medical College Hospital
Division name Department of Clinical oncology
Zip code
Address 3-2 Namiki, Tokorozawa-shi, Saitama 359-8513, Japan
TEL 04-2995-1511
Email wataru@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi
Organization Japan Clinical Cancer Research Organization
Division name Office
Zip code
Address 1-14-5 Ginza, Chuo-ku, Tokyo 104-0061, Japan
TEL 03-5579-9882
Homepage URL
Email jaccro@jaccro.or.jp

Sponsor
Institute Japan Clinical Cancer Research Organization
Institute
Department

Funding Source
Organization Japan Clinical Cancer Research Organization
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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
2013 Year 05 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
2013 Year 04 Month 23 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 07 Day
Last follow-up date
2014 Year 06 Month 30 Day
Date of closure to data entry
2014 Year 06 Month 30 Day
Date trial data considered complete
2014 Year 07 Month 23 Day
Date analysis concluded
2014 Year 08 Month 18 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 03 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012444

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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