UMIN-CTR Clinical Trial

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
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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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