UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	ECRIPS: Phase II study of docetaxel, cisplatin and cetuximab (TPE) followed by cetuximab with Concurrent Radiotherapy in Patients with local advanced Squamous cell carcinoma of the Head and Neck (LA-SCCHN).
Title of the study (Brief title)	Phase II study of docetaxel, cisplatin and cetuximab (TPE) followed by cetuximab with Concurrent Radiotherapy in Patients with LA-SCCHN (CSPOR-HN 01: ECRIPS)
Region	Japan

Condition
Condition	Head and Neck cancer
Classification by specialty	Medicine in general Hematology and clinical oncology Oto-rhino-laryngology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	evaluating the efficacy and safety of TPE followed by RT-E in patients with LA-SCCHN who have had no prior treatment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	Proportion of treatment completion
Key secondary outcomes	larynx function preservation, response rate, local progression-free survival, overall survival, progression-free survival, Safety

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Docetaxel+CDDP+ Cetuximab followed by Cetuximab+RT
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Histologically diagnosed primary squamous cell carcinoma Primary lesion located in the mesopharynx, hypopharynx, or larynx Resectable LA-SCCHN diagnosed within 4 weeks before enrollment Age between 20 and 75 years ECOG PS 0 or 1 No prior curative surgery for head and neck cancer, excluding diagnostic biopsy of cervical lymph nodes No prior RT, CT or endocrine therapy for the current or any other malignancy Maintenance of vital organ functions, as indicated by the following laboratory data obtained within 14 days before enrollment Written informed consent to the study signed by the patient
Key exclusion criteria	1) Evidence of distant metastasis. 2) Post-operative RT is intended. 3) Pregnancy or breastfeeding. 4) Prior therapy with Cetuximab or monoclonal antibody. 5) Medical or psychiatric condition that would not permit the subject to complete the trial or informed consent. 6) Uncontrollable diabetes or malignant hypertension or liver failure. 7) History of Pulmonary fibrosis, acute lung injury or interstitial pneumonia. 8) Active infection. Known HIV. 9) Known coronary artery disease, history of myocardial infarction within prior 12 months, uncontrollable arrhythmia, or uncontrollable cardiac failure. 10) Dental treatment with incision and drainage. 11) History of multiple cancers unless free of disease for at least three years. 12) Patient judged inappropriate for this trial by physicians.
Target sample size	55

Research contact person
Name of lead principal investigator	Sadamoto Zenda
Organization	National Cancer Center Hospital East
Division name	Radiation oncology
Address	6-5-1 Kashiwanoha Kashiwa chiba, Japan
TEL	04-7133-1111
Email	no@jp

Public contact
Name of contact person	Akira Yamao
Organization	Public health research foundation
Division name	Executive office of Comprehensive Support Project for Oncology Research
Address	1-1-7 Nishiwaseda, Shinjuku-ku, Tokyo, 169-0051 JAPAN
TEL	03-5287-2636
Homepage URL
Email	info@csp.or.jp

Sponsor
Institute	CSPOR-HN 01 executive committee
Institute
Department

Funding Source
Organization	Public health research foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	国立がん研究センター東病院 千葉県がんセンター 国立病院機構東京医療センター 兵庫県立がんセンター がん研究会有明病院 岩手医科大学附属病院 東海大学医学部付属病院 埼玉県立がんセンター 四国がんセンター 北海道大学病院 宮城県立がんセンター 奈良県立医科大学附属病院 近畿大学医学部附属病院 大阪市立総合医療センター 静岡県立静岡がんセンター 自治医科大学附属病院 愛知県がんセンター中央病院 神戸大学医学部附属病院 京都大学医学部附属病院 東京慈恵会医科大学附属病院 神戸市立医療センター中央市民病院 広島大学病院

Other administrative information
Date of disclosure of the study information	2013 Year 03 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 02 Month 06 Day
Anticipated trial start date	2013 Year 05 Month 01 Day
Last follow-up date	2017 Year 10 Month 31 Day
Date of closure to data entry	2017 Year 12 Month 31 Day
Date trial data considered complete	2017 Year 12 Month 31 Day
Date analysis concluded	2018 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 02 Month 01 Day
Last modified on	2018 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011634