UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004124 |
|---|---|
| Receipt number | 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 00:36:48 |
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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
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
Sponsor or person
Institute
Kinki university school of medicine
Department of clinical oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004953
