UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003889 |
|---|---|
| Receipt number | 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 22:59:26 |
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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
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
kkent@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004682
