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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021870
Receipt No. R000025187
Scientific Title Clinical trial of concurrent chemoradiotherapy (CCRT) with S-1 in patients with advanced head and neck squamous cell carcinoma, who is not eligible for CCRT with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) regimen
Date of disclosure of the study information 2016/04/11
Last modified on 2016/04/14

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Basic information
Public title Clinical trial of concurrent chemoradiotherapy (CCRT) with S-1 in patients with advanced head and neck squamous cell carcinoma, who is not eligible for CCRT with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) regimen
Acronym Clinical trial of concurrent chemoradiotherapy with S-1 in patients with advanced head and neck squamous cell carcinoma
Scientific Title Clinical trial of concurrent chemoradiotherapy (CCRT) with S-1 in patients with advanced head and neck squamous cell carcinoma, who is not eligible for CCRT with Docetaxel, Cisplatin and 5-Fluorouracil (TPF) regimen
Scientific Title:Acronym Clinical trial of concurrent chemoradiotherapy with S-1 in patients with advanced head and neck squamous cell carcinoma
Region
Japan

Condition
Condition 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 feasibility and the efficacy of radiotherapy and concurrent chemotherapy of S-1 (2 weeks administration and 1 week rest) in patients with resectable advanced (stage III, IV) squamous cell carcinoma of the head and neck, who could not be administered high dose chemotherapy because of complications or advanced age.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Progression free survival rate
Key secondary outcomes Response rate, treatment completion rate, Cause specific survival rate, Overall survival period, Safety

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 Administration of 2 courses (6 weeks) concurrent chemotherapy in which one course consists of S-1 65mg/m2 for 2 weeks administration followed by 1 week rest.
A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2Gy/day).
After a total dose of 40 Gy, all patients were clinically evaluated by endoscopy, and by computed tomography scan or magnetic resonance image. Patients with a 50% or greater decrease in the product of 2 perpendicular diameters of primary and neck tumors (responders) continued chemotherapy and completed radiotherapy. For non-responders with resectable tumor, definitive surgery was recommended. 4-6 weeks after the end of treatment, tumor evaluation will be carried out by biopsy, aspiration cytology, and image. If remaining cancer cells is detected in the patient, the patient have a operation.
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
85 years-old >
Gender Male and Female
Key inclusion criteria 1. histologically or cytologically confirmed squamous cell carcinoma
2. Primary lesion located in oropharynx, hypopharynx, or larynx diagnosed as stage III, IVA or IVB with no evidence of distant metastases
3. Age of more than 76 years, or who is note eligible for concurrent chemoradiotherapy with TPF regimen
4. measurable or assessable region
5. previously untreated
6. ECOG performance status are 0 or 1.
7. 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 >=2,000/ mm3
3) Platelet count >=100,000/ mm3
4) Hemoglobin >=10.0 g/dl
5) AST, ALT: 2.0 times of normal range in each institute
6) ALP: 2 times of normal range of each institute
7) T.bil: 1.5 times of normal range in each institute
8) serum Creatinine <=1.5 mg/dl
9) creatinine clearance >=30ml/min
8. expected more than 3 months survival from drug administration
9. written informed consent
10. Possible oral intake
Key exclusion criteria 1. with active double cancer
2. with sever complications (for example ; malignant hypertension, congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris, or abnormal cardiac rhythm which need to treat within 6 months, cerebrovascular accident within 6 months, cirrhosis, hemorrhagic gastrointestinal ulceration, diabetes that is loss of control, bleeding tendency)
3. with deverop fever and suspected infection
4. with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease)
5. with pleural effusion which need to treat or pericardial effusions
6. pregnant or nursing women or women who like be pregnant
7. with interstitial pneumonitis which is revealed from chest X ray or chest CT
8. with a history of mental disorder or treated it at the momen
9. with a history of sever drug allergy
10. with sever allergy to S-1
11. during any treatment with other pyrimidine analogue drug
12. during any treatment with Flucytosine
13. Physician concludes that the patient&#39;s participation in this trial is inappropriate

Target sample size 40

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

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Sano
Organization Yokohama City University, school of medicine
Division name Department of Otolaryngology - Head and Neck Surgery
Zip code
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
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
2016 Year 04 Month 11 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
Anticipated trial start date
2016 Year 03 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
2016 Year 04 Month 11 Day
Last modified on
2016 Year 04 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025187

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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