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Name:
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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021841
Receipt No. R000025182
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
Date of disclosure of the study information 2016/04/08
Last modified on 2019/04/11

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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/ctr_e/ctr_view.cgi?recptno=R000025182

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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