UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021841 |
|---|---|
| Receipt number | 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 09:53:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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's participation in this trial is inappropriate
Target sample size
50
Research contact person
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
noridate@yokohama-cu.ac.jp
Public contact
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
dsano@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025182
