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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||||||
Condition | squamous-cell carcinoma of head and neck | ||||||
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Jichi Medical University;
Aichi Cancer Center Hospital |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete |
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Date analysis concluded |
Other | |
Other related information | Study design : multicenter, observational study |
Management information | |||||||
Registered date |
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Last modified on |
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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 |