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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013858
Receipt No. R000016167
Scientific Title phase II trial of concurrent chemoradiotherapy (CCRT) with docetaxel + cisplatin + cetuximab for locally advanced squamous cell carcinoma of the head and neck
Date of disclosure of the study information 2014/05/01
Last modified on 2015/11/05

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Basic information
Public title phase II trial of concurrent chemoradiotherapy (CCRT) with docetaxel + cisplatin + cetuximab for locally advanced squamous cell carcinoma of the head and neck
Acronym Phase II trial of CCRT with TP + cetuximab regimen
Scientific Title phase II trial of concurrent chemoradiotherapy (CCRT) with docetaxel + cisplatin + cetuximab for locally advanced squamous cell carcinoma of the head and neck
Scientific Title:Acronym Phase II trial of CCRT with TP + cetuximab regimen
Region
Japan

Condition
Condition advanced squamous cell carcinoma of the head and neck
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of concurrent chemoradiotherapy with docetaxel + cisplatin + cetuximab in patients with untreated and advanced (stage III, VA-B) squamous cell carcinoma of the head and neck

Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes safety
acute adverse event (neutropenia) during primary treatment
Key secondary outcomes response rate, treatment comprehensive rate, disease-free survival, Overall survival

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
Interventions/Control_1 The chemotherapy regimen consisted of combination of three drugs: docetaxel (50mg/m2, day1), cisplatin (60mg/m2, day1), and weekly cetuximab (week 1, 400mg/m2, subsequent weeks, 250mg/m2). Two cycles of this regimen were given every 4 weeks concurrently with radiotherapy.
A total radiation dose of 70 Gray is planned with conventional fractionation (1.8-2.0 Gray/day)
Acute adverse events including nertropenia were evaluated with CTCAE ver.4.0
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1) histologically or cytologically confirmed squamous cell carcinoma of the head and neck
2) primary site is oral cavity, oropharynx, hypopharynx, or larynx
3) stage III, IVA, or IVB
4) age of 20-70 years
5) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
resectable or unresectable cases
6) cases with measurable or assessable region (RECICT v1.1)
7) untreated cases with first cancer
8) sufficient function of important organs
a) WBC: >=3,000/mm3
b) Neutrophyl: >=1,500/ mm3
c) Platelet: >=100,000/ mm3
d) Hemoglobin: >=9.0 g/dl
e) AST, ALT: <=3 times the upper limited of the normal range
f) sT.bil: <=2 times the upper limited of the normal range
g) Creatinin clearance: <=65 ml/min
9) HBsAg negative
10) written informed consent
Key exclusion criteria 1) with distant metastasis
2) nasopharyngeal cancer
3) post-operative chemoradiotherapy
4) with treatment history of cetuximab or with allergy to taxan, platinum analogue, or cetuximab or with a history of allergy
5) creatinin clearance < 65ml/min
6) with heart disease which is difficult to control
7) with interstitial pneumonitis or pulmonary fibrosis
8) with diabetic, hypertension, or liver dysfunction which is difficult to control
9) with infection which need to treat
10) with severe drug allergy
11) pregnant, women who like be pregnant, or man who doesn't agree to contraception during the treatment
12) doctor's decision not to be registered to this study

Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Oridate Nobuhiko
Organization Yokohama City University Graduate School of Medicine
Division name Department of Biology and Function in the Head and Neck
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL 045-787-2687
Email ycu_ent@med.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Oridate Nobuhiko
Organization Yokohama City University Graduate School of Medicine
Division name Department of Biology and Function in the Head and Neck
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL 045-787-2687
Homepage URL
Email ycu_ent@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Otorhinolaryngology, Yokohama City University Medical Center
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 横浜市立大学附属病院(神奈川県)、横浜市立大学附属市民総合医療センター(神奈川)

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 01 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
2014 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 01 Day
Last modified on
2015 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016167

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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