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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001144
Receipt No. R000001388
Scientific Title Randomized phase II syudy of weekly docetaxel versus S-1 and concurrent radiothrapy for stage III and IV laryngeal, oropharyngeal, and hypopharyngeal cancer in elderly patients or patients with complications
Date of disclosure of the study information 2008/05/01
Last modified on 2015/01/13

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Basic information
Public title Randomized phase II syudy of weekly docetaxel versus S-1 and concurrent radiothrapy for stage III and IV laryngeal, oropharyngeal, and hypopharyngeal cancer in elderly patients or patients with complications
Acronym Phase II trial of concurrent chemoradiotherapy in elderly patients or patients with complications
Scientific Title Randomized phase II syudy of weekly docetaxel versus S-1 and concurrent radiothrapy for stage III and IV laryngeal, oropharyngeal, and hypopharyngeal cancer in elderly patients or patients with complications
Scientific Title:Acronym Phase II trial of concurrent chemoradiotherapy in elderly patients or patients with complications
Region
Japan

Condition
Condition laryngeal, oropharyngeal,
and hypopharyngeal cancer
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) or weekly docetaxel 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 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes locoregional relapse free survival, survival with primary organ preservation, overall survival, treatment completion rate, incidence and severity of adverse events, economic analysis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Docetaxel administration group:
Administration of 5 courses (5 weeks) concurrent chemotherapy in which one course consists of docetaxel 12mg/m2 weekly. 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 S-1 administration group:
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_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)stage 3 or 4 with no evidence of distant metastases
3)resectable squamous cell carcinoma
4)measurable or assessable region
5)Eastern Cooperative Oncology
Group (ECOG) performance status (PS) of 0 or 1
6)age of 20-85 years
7)sufficient function of important organs
a) WBC: >=4,000/mm3 and <12,000/mm3
b) Neutrophyl: >=2,000/ mm3
c) Platelet: >=100,000/ mm3
d) Hemoglobin: >=11.0 g/dl
e) AST, ALT: 2.0 times of normal range in each institute
f) sT.bil: 1.5 times of normal range in each institute
g) ALP: 2 times of normal range of each institute
h) sCreatinin: <=1.5 mg/dl
l) Ccr: >30ml/min
8)expected more than 3 months survival from drug administration
9)written informed consent
Key exclusion criteria 1)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)
2)with deverop fever and suspected infection
3)with motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease)
4)with pleural effusion which need to treat or pericardial effusions
5)with active double cancer
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 moment
9)with sever allergy to docetaxel or S-1, or with a history of sever allergy
10)doctor's decision not to be registered to this study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahide Taguchi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Biology and Function in the Head and Neck
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL 045-787-2687
Email ttaguchi@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahide Taguchi
Organization Yokohama City University Graduate School of Medicine
Division name Department of Biology and Function in the Head and Neck
Zip code
Address 3-9, Fukuura, Kanazawa-ku, Yokohama,236-0004
TEL 045-787-2687
Homepage URL
Email ttaguchi@yokohama-cu.ac.jp

Sponsor
Institute study group of chemoradiotherapy of the head and neck cancer
Institute
Department

Funding Source
Organization study group of chemoradiotherapy of the head and neck cancer
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 横浜市立大学附属病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2008 Year 05 Month 01 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 Terminated
Date of protocol fixation
2007 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 04 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 05 Month 01 Day
Last modified on
2015 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001388

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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