UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010639 |
|---|---|
| Receipt number | 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 09:58:11 |
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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
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
jaccro@jaccro.or.jp
Sponsor or person
Institute
Japan Clinical Cancer Research Organization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012444
