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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009698
Receipt No. R000011370
Scientific Title Phase II crinical trial of cetuximab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer
Date of disclosure of the study information 2013/01/07
Last modified on 2018/06/25

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Basic information
Public title Phase II crinical trial of cetuximab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer
Acronym Cetuximab Rechallenge
Scientific Title Phase II crinical trial of cetuximab rechallenge with KRAS wild-type unresectable/recurrent colorectal cancer
Scientific Title:Acronym Cetuximab Rechallenge
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This phase II prospective study aims
to investigate the activity of a retreatment with a cetuximab-based therapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Response rate(RR)
Key secondary outcomes Progression free survival(PFS)
Overall survival(OS)
Safety

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 This is a multicentric phase II trial that examines patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab- plus FOLFOX/FOLFIRI therapy and then a progression of disease, during cetuximab-based therapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another Cetuximab based chemotherapy.
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)Histopathological confirmation of Adenocarcinoma
2EGFR expression confirmed by immunohistochemistry either in the primary tumor or in metastatic tumor lesion
3)KRAS wild type (in codon 12, 13) confirmed, either in the primary tumor or in metastatic tumor lesion
4)Patients who had a clinical benefit [confirmed stable disease (SD) for at least 6 months or clinical response] after a line of cetuximab based chemotherapy and then a progression of disease or intolerable of adverse events, during cetuximab based chemotherapy, for which underwent a new line chemotherapy and finally, after a clear new progression of disease, were retreated with the same or another cetuximab chemotherapy.
5)Age of 20 or more years old
6)ECOG performance status of 0 to 2
7)Presence of at least one measurable lesion according to RECIST
8)Sufficient function of important organs
1. WBC:>= 2,000 /mm3
2. Neu: >= 1,500 /mm3
3. Platelet: >= 75,000 /mm3
4. Hemoglobin: >= 8.0 g/dL
5. Sr.bil : <= 2.5 mg/dL
6. AST, ALT: <= upper limits of normal (ULN)x2.5 (patients with liver metastasis; AST, ALT : <= ULNx5.0)
7. Serum creatinine: <= ULNx1.5
9)Expected more than 3 months survival
10)With written informed consent
Key exclusion criteria 1)Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2)Patients with brain metastasis which have symptoms or patients with history of brain metastasis
3)Severe wattery diarrhea
4)Severe infectious disease
5)Severe complications (interstitial lung disease or pulmonary fibrosis, kidney failure, hepatic failure, uncontrolable diabetes, uncontrolable hypertension)
6)Severe carcinomatous ascites, pleural effusion or pericardial cavity effusion
7)Pregnant or lactating women or women of childbearing potential, and no birth-control
8)Patients with history of serious hypersensitivity

Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyoshi Fujiwara
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7257
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Nagasaka
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Gastroenterological Surgery
Zip code
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL 086-235-7257
Homepage URL
Email

Sponsor
Institute Okayama Molecular Target-Based Drugs Society for Cancer of the Colon and Rectum
Institute
Department

Funding Source
Organization Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
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

Other administrative information
Date of disclosure of the study information
2013 Year 01 Month 07 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 Terminated
Date of protocol fixation
2012 Year 12 Month 19 Day
Date of IRB
Anticipated trial start date
2013 Year 01 Month 07 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
2013 Year 01 Month 05 Day
Last modified on
2018 Year 06 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011370

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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