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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002168
Receipt No. R000002657
Scientific Title Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Date of disclosure of the study information 2009/07/18
Last modified on 2015/01/13

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Basic information
Public title Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Acronym Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Scientific Title Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Scientific Title:Acronym Phase II trial of S-1 with concurrent radiotherapy in T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and toxicity of S-1 plus concurrent radiotherapy in patients with T2N0M0 laryngeal, mesopharynx, hypopharynx cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes local control rate
Key secondary outcomes response rate, treatment completion rate, local control time, progression free time, overall survival, 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 S-1 is administered orally at 60 mg/m2 for 14 consecutive days followed by a 7 days rest. A total radiation dose of 70 Gy is planned with conventional fractionation (1.8-2.0Gy/day). Cycles are repeated every 3 weeks until 3 courses.
At a radiation dose of 40 Gy, tumor evaluation is carried out intermediary by inspection or image. If patient is in partial response or complete response, concurrent chemoradiation is continued until 70 Gy. 8 weeks after the end of treatment, tumor evaluation is carried out by imaging and biopsy. If remaining cancer cell is detected, 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
80 years-old >
Gender Male and Female
Key inclusion criteria 1)histologically or cytologically confirmed squamous cell carcinoma
2)stage II (T2N0M0) laryngeal, mesopharunx, and hypopharynx cancer with no evidence of distance metastases.
3)age: >=20 and <80
4)with measurable region
5)without prior treatment
6)Performance Statues: 0-1(ECOG)
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: >=10g/dl
e)GOT, GPT: 2.0 times of normal range in each institute
f)ALP: 2.0 times of normal range in each institute
g)sT.bil: 2.0 times of normal range in each institute
h)sCreatinin: normal range in each institute
i)Ccr: >=60 ml/min/body
8)expected more than 3 months survival from drug administration
9)written informed consent
10)with ability of oral intake
Key exclusion criteria 1)with active double cancer
2)with severe complications (congested heart failure, coronary insufficiency, myocardial infarction, angina pectoris or abnormal cardiac rhythm which need to treat, history of cerebrovascular accident, hemorrhagic gastrointestinal ulceration, uncontrolled diabetes, renal failure, active hepatitis, liver cirrhosis)
3)with develop 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 and men with partner willing to get pregnant
7)with interstitial pneumonitis which is revealed from chest X ray and chest CT
8)with history of mental disorder or treating it at the moment
9)with history of severe allergy
10)with severe allergy to S-1
11)patients receiving 5-FU based chemotherapy
12)patients receiving Flucytosine
13)doctor's decision not to be registered to this study
Target sample size 35

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiko Oridate
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 noridate@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takahide Taguchi
Organization Yokohama City University Hospital
Division name Department of Otorhinolaryngology
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 Yokohama City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University Graduate School of Medicine
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)、横浜市立大学附属市民総合医療センター(神奈川県)、神奈川県立がんセンター(神奈川県)、藤沢市民病院(神奈川県)、横浜南共済病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
From August 2009 to October 2012, 37 patients were evaluated for the study. The overall response rate was 100%. The 3-year local control rate was 89.0% (95% confidence interval (CI), 78.9-99.2%), and the 3-year overall survival rate was 97.2% (95% CI, 91.8-100%). Mucositis and dermatitis in the radiation field were the most common acute adverse events observed. The rates of Grade 3 mucositis and dermatitis were 27% and 35%, respectively. No patients experienced Grade 4 acute adverse events. The treatment completion rate was 89.2%
As a conclusion, CCRT with S-1 was safe and effective in improving local control for stage II SCC of the pharynx or larynx.
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 Completed
Date of protocol fixation
2009 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2014 Year 06 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
2009 Year 07 Month 07 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=R000002657

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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