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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000003889
Receipt No. R000004682
Scientific Title Phase I/II Trial of S-1 and Nedaplatin with concurrent radiotherapy in locally advanced mesopharynx, hypopharynx cancer
Date of disclosure of the study information 2010/07/09
Last modified on 2016/02/16

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Basic information
Public title Phase I/II Trial of S-1 and Nedaplatin with concurrent radiotherapy in locally advanced mesopharynx, hypopharynx cancer
Acronym Phase I/II Trial of S-1 and Nedaplatin with concurrent radiotherapy in locally advanced mesopharynx, hypopharynx cancer
Scientific Title Phase I/II Trial of S-1 and Nedaplatin with concurrent radiotherapy in locally advanced mesopharynx, hypopharynx cancer
Scientific Title:Acronym Phase I/II Trial of S-1 and Nedaplatin with concurrent radiotherapy in locally advanced mesopharynx, hypopharynx cancer
Region
Japan

Condition
Condition Mesopharyngeal cancer
Hypopharyngeal Cancer
Classification by specialty
Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Phase I part: to evaluate maximum tolerated dose to determine recommended dose of Nedaplatin in combination with a fixed dose of TS-1 and radiation in patients with local advanced mesopharynx, hypopharynx cancer.

Phase II part: to evaluate the efficacy and toxicity of S-1 and Nedaplatin plus concurrent radiotherapy in patients with local advanced mesopharynx, hypopharynx cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: To determinate maximum tolerated dose and recommended dose
Phase II: complete response rate
Key secondary outcomes Phase I: safety
Phase II: response rate, time to laryngeal preservation, local control rate, relapse free survival, overall survival, safety, time to treatment failure, QOL

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 Combination chemotherapy consists of TS-1 (80-120 mg/day, day 1 through 14, day 29 through 42), Nedaplatin (80-100 mg/m2, day 1 and day 29). A total radiation dose of 60 Gy is planned with conventional fractionation (2 Gy/day).
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-IVA mesopharunx, and hypopharynx cancer
3)age: >=20 and <80
4)with measurable region
5)without prior radical surgery
6)without prior treatment
7)Performance Statues: 0-1(ECOG)
8)sufficient function of important organs
a)WBC: >=3,500/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 the upper limit of normal range in each institute
f)ALP: <= 2.0 times of the upper limit of normal range in each institute
g)sT.bil: <= 1.5 times of the upper limit of normal range in each institute
h)sCreatinin: <= the upper limit of normal range in each institute
i)Ccr: >=60 ml/min/body
9)expected more than 3 months survival from drug administration
10)written informed consent
11)with ability of oral intake
Key exclusion criteria 1)active double cancer
2)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)develop fever and suspected infection
4)motor palsy, peripheral neuropathy or edema (exclude the disorder which derives from primary disease)
5)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)interstitial pneumonitis which is revealed from chest X ray and chest CT
8)history of mental disorder or treating it at the moment
9)history of severe allergy
10)severe allergy to S-1 or Nedaplatin
11)patients receiving 5-FU based chemotherapy
12)patients receiving Flucytosine
13)doctors decision not to be registered to this study
Target sample size 43

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makito Okamoto
Organization Kitasato University School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.
TEL 042-778-8111
Email kkent@med.kitasato-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Kano
Organization Kitasato University School of Medicine
Division name Department of Otorhinolaryngology
Zip code
Address 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375.
TEL 042-778-8111
Homepage URL
Email kkent@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine
Institute
Department

Funding Source
Organization Kitasato University 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 北里大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 09 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 Preinitiation
Date of protocol fixation
2010 Year 05 Month 19 Day
Date of IRB
Anticipated trial start date
2010 Year 07 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
2010 Year 07 Month 08 Day
Last modified on
2016 Year 02 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004682

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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