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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011911
Receipt No. R000013802
Scientific Title Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab
Date of disclosure of the study information 2013/10/01
Last modified on 2019/11/29

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Basic information
Public title Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab
Acronym Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab
Scientific Title Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab
Scientific Title:Acronym Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab
Region
Japan

Condition
Condition squamous-cell carcinoma of head and neck
Classification by specialty
Medicine in general Hematology and clinical oncology Oto-rhino-laryngology
Radiology Oral surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of therapy including cetuximab for Japanese patients with squamous-cell carcinoma of head and neck.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes One-year progression-free survival
One-year overall survival
Key secondary outcomes One-year progression-free survival
Proportion of treatment completion
Response rate
Adverse event rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Primary site : oral cavity, oropharynx, hypopharynx and larynx
2)Histologically proven squamous cell carcinoma
3)Locally advanced disease(LA-SCCHN) for stage III-IVB, or recurrent and metastatic disease which is not candidate for local treatment
4)Patient is planned for following treatments
4-1)Radiotherapy for Locally advanced disease (LA-SCCHN) weekly cetuximab (at least one time) is combined with radiotherapy of >=60 Gy
4-2)Chemotherapy for recurrence or metastatic disease Cetuximab combined with any type of chemotherapy
5)ECOG PS : 0-2
6)Japanese Nationality
7)Age >=20
8)Written Informed consent
9)Consent for contraception(female with probability for pregnancy or male with ability of reproduction)
10)Patients received cetuximab after 1st Jan 2013
Allowed for patient who have registered in other trials or already treated with cetuximab at registration
Key exclusion criteria 1)Previous history of cetuximab treatment before 31th Dec 2012
2)Severe allergic reaction (G3-4) of any component in Erbitax
3) Critical comorbidity otherwise head and neck cancer
4) Second primary cancer except when there has been no evidence of the disease for more than 3 years without any treatment. (Exclude of carcinoma in situ or mucosal cancer which is estimated as stable by local treatment)
5)Positive HbsAg without adequate anti-viral treatment
6) Pregnancy or lactation
7)Any inappropriate reason for registration by physicians
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirofumi Fujii; Takeshi Kodaira
Organization Jichi Medical University;
Aichi Cancer Center Hospital
Division name Department of Clinical Oncology; Department of Radiation Oncology
Zip code
Address 3311-1 Yakushiji, Shimotsuke, Tochigi; 1-1 Kanoko-den, Chikusa-ku, Nagoya, Aichi
TEL 052-762-6111
Email 109103@aichi-cc.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yosuke, Ota
Organization Hyogo Cancer Center
Division name Department of Radiation Oncology
Zip code
Address 13-70 kitaojimachi, akashi-shi, Hyogo
TEL 078-929-1151
Homepage URL
Email yosukeota@hp.pref.hyogo.jp

Sponsor
Institute Japanese Oncology Radiation Study Group
Institute
Department

Funding Source
Organization Merck Serono Co,Ltd
Organization
Division
Category of Funding Organization Profit organization
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 10 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
2013 Year 08 Month 21 Day
Date of IRB
2013 Year 07 Month 13 Day
Anticipated trial start date
2013 Year 12 Month 12 Day
Last follow-up date
2019 Year 03 Month 29 Day
Date of closure to data entry
Date trial data considered complete
2019 Year 05 Month 07 Day
Date analysis concluded

Other
Other related information Study design : multicenter, observational study

Management information
Registered date
2013 Year 09 Month 30 Day
Last modified on
2019 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013802

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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