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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004124
Receipt No. R000004953
Scientific Title Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer
Date of disclosure of the study information 2010/08/30
Last modified on 2010/08/30

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Basic information
Public title Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer
Acronym Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer
Scientific Title Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer
Scientific Title:Acronym Phase1 trial of Cetuximab/S-1 combination therapy for Advanced/Recurrent Colorectal Cancer
Region
Japan

Condition
Condition Advanced/Recurrent Colorectal Cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of cetuximab and S-1 combinaton therapy in patients with metastatic colorectal cancer.
Basic objectives2 Others
Basic objectives -Others pharmacokinetics,time to success treatment, overall survival,tumor response, quality of life
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I

Assessment
Primary outcomes To determine the recomend dose of cetuximab and S-1 combinaton therapy
Key secondary outcomes pharmacokinetics(PK/PD), a time to success treatment, overall survival, tumor response, quality of life

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 S-1 combination therapy
cetuximab : Weekly administration 400 mg/m2 for the 1st time (day1), 250mg/m2/week for the 2nd time or another (day8,15,..)
S-1 : 60 or 80 mg/m2/2weeks/day1-14, 4weeks
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)Patients with histologically proven colorectal cancer, and Unresectable or recurrent colorectal camcer
patient who treatment of pallitive radiation can enroll to time that radiaton ended 1 week
(2)EGFR protein detected by tumor sample
(3)Patient was not treated to cetuximab
(4)Age >= 20 and =< 75.
(5)ECOG performance status of 0,1,and 2.
(6)Patient can be oral ingestion.
(7) Unresectable primary tumor or with one or more unresectable metatatic tumor
Measurable or evaluable disease (measurable lesions in RECIST criteria is unnecessary) within 30 days before registration.
(8)Adequate function of vital organs, including normal hematopoietic function, normal liver function and normal renal function as evidenced by the following data within two weeks before registration.
(9)Resistrar evaluation patients who survive 12 weeks.
(10)Patient can be contraception time to therapy ended 3 months.
(11)Patient was explain of this trial and put patient's signature to a document.
Key exclusion criteria (1)A case with the interstitial pneumonia that is clear by chest CT or pulmonary fibrosis.
(2)A case receiving flucytosine (a pyrimidine system antifungal agent fluoride).
(3)A case with a history of serious drug allergy.
(4)The case with pleural effusion, ascitic fluid needing treatment such as the drainage and the pericardial fluid.
(5) The case with serious heart disorder, myocardial infarction within six months, hypertension having poor control, bacterial infection and fungal infection of the activity and other serious complications (haemorrhage of digestive tract).
(6)A case to have a short bowel syndrome merger or diarrhea (watery feces) continuously.
(7) Intestinal paralysis, a case with bowel obstruction.
(8) Metastases to brain case with the symptom.A case (as for the metastases to brain case that a symptom was stable by metastases to brain case and radiotherapy and medical treatment without the symptom, possible registration) to need the antihydropic including the steroid of the symptom control purpose.
(9)A case with the diabetes mellitus inadequate control.
(10)The case that it was judged mental disorder to become the clinical problem to have difficulty in registration to this study.
(11)A case to have pregnant or pregnant possibilities, the case that there is not of the intention to prevent conception and the case that we are nursing.
(12)In addition, the case that we judged to be inadequate though the medical attendants conducted this study
Target sample size 21

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Soichi Fumita
Organization Kinki university school of medicine
Division name Department of clinical oncology
Zip code
Address 377-1,Onohiasi, Osakasayama-city, Osaka
TEL 072-366-0221
Email

Public contact
Name of contact person
1st name
Middle name
Last name Soichi Fumita
Organization Kinki university school of medicine
Division name Department of clinical oncology
Zip code
Address 377-1,Onohiasi, Osakasayama-city, Osaka
TEL 072-366-0221
Homepage URL
Email

Sponsor
Institute Kinki university school of medicine
Department of clinical oncology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 近畿大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 08 Month 30 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 Open public recruiting
Date of protocol fixation
2010 Year 01 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 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
2010 Year 08 Month 30 Day
Last modified on
2010 Year 08 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004953

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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