UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011911 |
|---|---|
| Receipt number | 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 13:30:20 |
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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
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
yosukeota@hp.pref.hyogo.jp
Sponsor or person
Institute
Japanese Oncology Radiation Study Group
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013802
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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