Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab

Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab - Observation study for Japanese patients with head and neck cancer by combination therapy with cetuximab

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000011911

Enrollment

300

Registered

2013-10-01

Start date

2013-12-12

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

squamous-cell carcinoma of head and neck

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
One-year progression-free survival One-year overall survival	—

Secondary

Measure	Time frame
One-year progression-free survival Proportion of treatment completion Response rate Adverse event rate	—

Countries

Japan

Contacts

Public ContactYosuke, Ota

Hyogo Cancer Center Department of Radiation Oncology

yosukeota@hp.pref.hyogo.jp078-929-1151

Outcome results