UMIN-CTR Clinical Trial

Basic information
Public title	Clinical trial of concurrent chemoradiotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) in patients with locally advanced head and neck squamous cell carcinoma
Acronym	Clinical trial of concurrent chemoradiotherapy with TPF regimen in patients with locally advanced HNSCC
Scientific Title	Clinical trial of concurrent chemoradiotherapy with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) in patients with locally advanced head and neck squamous cell carcinoma
Scientific Title:Acronym	Clinical trial of concurrent chemoradiotherapy with TPF regimen in patients with locally advanced HNSCC
Region	Japan

Condition
Condition	Locally advanced head and neck squamous cell carcinoma
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, and 5-fluorouracil (TPF) chemotherapy in patients with locally advanced head and neck squamous cell carcinoma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Locoregional free survival
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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. Previously untreated patients with measurable lesions. 2. Pathologically confirmed head and neck squamous cell carcinoma (HNSCC). 3. Primary lesion located in maxillary sinus, oral cavity, nasopharynx, oropharynx, hypopharynx, or larynx. 4. Clinical or Pathological stage III, IVA or IVB. 5. Surgically resectable. 6. Age of 20-75 years. 7. ECOG performance status are 0 or 1. 8. 24-h creatinine clearance >=65 ml/min 9. With adequate major organ functions within 14 days before trial entry, as defined below: 1) White blood cell count >= 3,000/mm3, 12,000/mm3 < 2) Neutrophil count >= 2,500/mm3 3) Platelet count >= 100,000/mm3 4) Hemoglobin >= 9.0 g/dL 5) Total Bilirubin < 1.5 mg/dL 6) AST, ALT <= 100IU/L 7) serum Creatinine < 1.2 mg/dL 10. No severe complications 11. No concurrent malignancies in 3 years before trial entry 12. Written informed consent must be taken by patients
Key exclusion criteria	1. History of the serious hypersensitivity for drugs used in this trial 2. The needs to use phenytoin or warfarin potassium during this trial. 3. 24-h creatinine clearance <65 ml/min 4. Active infection 5. Active digestive tract disorder 6. Evidence of interstinal lung disease, or pulmonary fibrosis 7. Evidence of uncontrolled diabetes mellitus 8. Evidence of uncontrolled cardiovascular disease 9. Severe hepatic dysfunction 10. Severe watery diarrhea 11. Lactating, pregnant or possibly pregnant women, or those willing to become pregnant 12. Physician concludes that the patient&#39;s participation in this trial is inappropriate
Target sample size	50

Research contact person
Last name of lead principal investigator	1st name Nobuhiko Middle name Last name Oridate
Organization	Yokohama City University, school of medicine
Division name	Department of Otolaryngology - Head and Neck Surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2800
Email	noridate@yokohama-cu.ac.jp

Public contact
1st name of contact person	1st name Daisuke Middle name Last name Sano
Organization	Yokohama City University, school of medicine
Division name	Department of Otolaryngology - Head and Neck Surgery
Zip code	236-0004
Address	3-9 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
TEL	045-787-2800
Homepage URL
Email	dsano@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University hospital
Institute
Department

Funding Source
Organization	None
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	Yokohama City Hospital
Address	1-1-1 Fukuura, Kanazawa-ku, Yokohama, 236-0004, Japan
Tel	045-370-7627
Email	rinri@yokohama-cu.ac.jp

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	2016 Year 04 Month 08 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	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 18 Day
Date of IRB	2015 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 03 Month 01 Day
Last follow-up date	2025 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	prospective observational study

Management information
Registered date	2016 Year 04 Month 08 Day
Last modified on	2019 Year 04 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025182