UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004403
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last 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
Email

Public contact
1st name of contact person
1st name
Middle name
Last name
Organization Kanagawa Cancer Center
Division name Gastrointestinal Surgery
Zip code
Address
TEL
Homepage URL
Email shiozawam@kcch.jp

Sponsor
Institute Kanagawa Cancer Center
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005263

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.