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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009928
Receipt No. R000011634
Scientific Title 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).
Date of disclosure of the study information 2013/03/10
Last modified on 2018/10/03

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Basic information
Public title 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).
Acronym Phase II study of docetaxel, cisplatin and cetuximab (TPE) followed by cetuximab with Concurrent Radiotherapy in Patients with LA-SCCHN (CSPOR-HN 01: ECRIPS)
Scientific Title 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).
Scientific Title:Acronym 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
1st name
Middle name
Last name Sadamoto Zenda
Organization National Cancer Center Hospital East
Division name Radiation oncology
Zip code
Address 6-5-1 Kashiwanoha Kashiwa chiba, Japan
TEL 04-7133-1111
Email no@jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Yamao
Organization Public health research foundation
Division name Executive office of Comprehensive Support Project for Oncology Research
Zip code
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)

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 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

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 02 Month 06 Day
Date of IRB
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

Other
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

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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