UMIN-CTR Clinical Trial

Basic information
Public title	Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
Acronym	Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
Scientific Title	Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
Scientific Title:Acronym	Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study
Region	Japan

Condition
Condition	Head and neck squamous cell carcinoma at stage III and IV
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy and safety of weekly administration of cisplatin and docetaxel concurrently combined with conventional radiotherapy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate
Key secondary outcomes	Survival rate, organ preservation rate, safety

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Concurrent chemoradiotherapy Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 60-70Gy/30-35fractions for non-nasopharyngeal cancer, or 1.8Gy/fraction/day, 5fractions/week, total dose of 70.2Gy/39fractions for nasopharyngeal cancer Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses Adjuvant chemotherapy of 2 or more than 2 courses of TPF (CDDP+DOC+5-FU) is scheduled for technically unresectable cases.
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	1) no tumor-specific pretreatment 2) no prior radiation against the same field as currently scheduled 3) estimable or measurable lesion 4) Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 5) expected survival duration for > 3months after the biginning of the treatment 6) no major impairment of liver, kidney, or bone marrow, fulfilling the condition of AST/ALT <2times the upper limit of normal, BUN <25mg/dl, serum creatinine <1.5mg/dl, creatinine clearance >60ml/min, white blood cell count >4000/mm3, neutrophil count >2000/mm3, and platelet count >100,000/mm3 7) no evidence of active infection or fever >38C 8) written informed consent
Key exclusion criteria	1) interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT 2) major heart/lung disorders, or uncontrolled diabetes mellitus 3) distant metastases or second primary cancer except when there has been no evidence of the disease for more than 24 months without any treatment and when the disease is superficial 4) major pulmonary effusion or ascites 5) neuropathy or edema 6) pregnancy or lactation 7) history of major allergy to medicine 8) long use of steroid
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hidenori Inohara
Organization	Osaka University School of Medicine
Division name
Zip code
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-5056
Email	hinohara@ent.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hidenori Inohara
Organization	Osaka University School of Medicine
Division name	Department of Otolaryngology
Zip code
Address	2-2 Yamadaoka, Suita, Osaka
TEL	06-6879-5056
Homepage URL
Email	hinohara@ent.med.osaka-u.ac.jp

Sponsor
Institute	Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine
Institute
Department

Funding Source
Organization	Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information	2006 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	CR rate 71%, 2-year overall survival 82%, and 4-year overall survival 68% for technically resectable disease. CR rate 45%, 2-year overall survival 58%, and 4-year overall survival 44% for technically unresectable disease.
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	2004 Year 03 Month 04 Day
Date of IRB
Anticipated trial start date	2006 Year 01 Month 01 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	2006 Year 01 Month 17 Day
Last modified on	2014 Year 12 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000394

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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