UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004403 |
|---|---|
| Receipt number | R000005263 |
| Scientific Title | A phase I/II study of Cetuximab combined with irinotecan and S-1 as first line therapy in metastatic colorectal cancer patients with KRAS wild type |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2016/04/18 09:58:31 |
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Basic information
Public title
A phase I/II study of Cetuximab combined with irinotecan and S-1 as first line therapy in metastatic colorectal cancer patients with KRAS wild type
Acronym
A phase I/II study of Cetuximab combined with irinotecan and S-1 as first line therapy in metastatic colorectal cancer patients with KRAS wild type
Scientific Title
A phase I/II study of Cetuximab combined with irinotecan and S-1 as first line therapy in metastatic colorectal cancer patients with KRAS wild type
Scientific Title:Acronym
A phase I/II study of Cetuximab combined with irinotecan and S-1 as first line therapy in metastatic colorectal cancer patients with KRAS wild type
Region
| Japan |
Condition
Condition
advanced colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and safety of combination therapy with Cetuximab, S-1 and irinotecan in patients with KRAS wild type advanced colorectal cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Phase I study
To evaluate feasibility
Phase II study
Response rate
Key secondary outcomes
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; bi-weekly administration 500mg/m2.
Irinitecan is administered as an intravenous infusion at a dose of 120mg/m2 on day 1 and 15. And TS-1 is orally administered on days 1-14 of a 28-day cycle. Administration dose of TS-1 is based BSA : BSA<1.25m2, 40mg twice daily; 1.25-1.5m2, 50mg twice daily; >1.5m2, 60mg twice daily.
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 advanced or metastatic colorectal cancer.
2) Unresectable advanced or metastatic colorectal cancer
3) EGFR expressed and KRAS wild type in codon 12 and 13
4) Presence of measurable lesion(RECIST )
5) No prior chemotherapy or radiotherapy for metastatic tumor.
6) Age between 20 to 75 years.
7) ECOG performance status 0.
8) Life expectancy of more than 16 weeks.
9) Adequate hematological (absolute white blood cell count >3000/mm3, neutrophil count >1500/mm3, platelets >100000/mm3, Hb >10 g/dl), hepatic (AST and ALT within 2 times the upper limit of normal for the institution, serum bilirubin level below 1.5 mg/dl) and renal (serum creatinine level below 1.5 mg/dl and BUN under 25 mg/dl) function, with at least one measurable site of disease (>1 cm in at least one dimension). No patients accepted into this had received any prior chemotherapy, except for adjuvant chemotherapy completed more than 6 months before study entry.
10) Written informed consent
11) Protocol was approved by the institutional ethics committee.
Key exclusion criteria
Patients are excluded from this trial for any of the following exclusion criteria: symptomatic infectious disease, bleeding tendency, severe heart disease, pre-existing symptomatic peripheral neuropathy, active double cancer, symptomatic ascites, pregnancy, breast feeding, obstructive bowel disease, severe diabetes mellitus requiring insulin or past history of drug allergy.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Shiozawa |
Organization
Kanagawa Cancer Center
Division name
Gastrointestinal Surgery
Zip code
Address
Kanagawa Cancer Center, 1-1-2 Nakao, Asahi-ku, Yokohama, 241-0815, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Kanagawa Cancer Center
Division name
Gastrointestinal Surgery
Zip code
Address
TEL
Homepage URL
shiozawam@kcch.jp
Sponsor or person
Institute
Kanagawa Cancer Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Local Government
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
| 2010 | Year | 11 | Month | 01 | 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
Completed
Date of protocol fixation
| 2010 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 18 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 18 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 18 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005263
