UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013858 |
|---|---|
| Receipt number | 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 13:41:53 |
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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
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
ycu_ent@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Biology and Function in the Head and Neck, Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016167
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