UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009928 |
|---|---|
| Receipt number | 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 17:09:07 |
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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
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
info@csp.or.jp
Sponsor or person
Institute
CSPOR-HN 01 executive committee
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011634
