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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000012074
Receipt No. R000014113
Scientific Title Phase I/II trial of S-1+Nedaplatin+Cetuximab for recurrent/metastatic head and neck squamous cell carcinoma
Date of disclosure of the study information 2013/11/18
Last modified on 2013/10/18

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Basic information
Public title Phase I/II trial of S-1+Nedaplatin+Cetuximab for recurrent/metastatic head and neck squamous cell carcinoma
Acronym Phase I/II trial of S-1+Nedaplatin+Cetuximab for recurrent/metastatic head and neck cancer
Scientific Title Phase I/II trial of S-1+Nedaplatin+Cetuximab for recurrent/metastatic head and neck squamous cell carcinoma
Scientific Title:Acronym Phase I/II trial of S-1+Nedaplatin+Cetuximab for recurrent/metastatic head and neck cancer
Region
Japan

Condition
Condition 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
efficacy and safety in the S-1+Nedaplatin+Cetuximab therapy against recurrent/metastatic head and neck cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase I,II

Assessment
Primary outcomes Phase I: Dose limited toxicity

Phase II: response rate
Key secondary outcomes Phase II: Overall survival, disease free survival, disease control rate, 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, Nedaplatin, Cetuximab
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
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) Histologically diagnosed primary squamous cell carcinoma
2) Proven recurrent or metastatic head and neck cancer (except for epipharynx)
3) Measurable disease
4) Primary radiotherapy and chemotherapy are permitted if the treatment has been completed at least 4 weeks before patient selection.
5) Age of 20-75 years
6) ECOG PS 0 or 1
7) Life expectancy of at least 3 months
8) Adequate organ function
9) Written informed consent to the study signed by the patient
10) the patient who can take meidicine by mouth

Not amenable for local treatment for recurrent/ metastatic disease

No prior chemotherapy including nedaplatin for the current malignancy

Adequate organ function

Life expectancy of greater than 3 months

Women of child-bearing potential and men who are able to father a child agree with using adequate contraception

Written informed consent to the study signed by the patient
Key exclusion criteria 1) Past history of allergy against S-1, Nedaplati or cetuximab
2) pregnancy or the man who wants partner's pregnancy
3) active double cancer
4) active infection disesase
5) Current administration of Flucytosine, fenitoin or warfarin
6) Positivity for hepatitis B or Hepatitis C antigen
7) severe skin disesase
8) interstitial pneumonia
9) severe diarrhea
10) severe renal disease
11) Other significant disease that in the investigator's opinion would exclude the subject from the trial
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naoyuki Kohno
Organization Kyorin University
Division name Department of Otolaryngology
Zip code
Address 6-20-2, Shinkawa , Mitaka, Tokyo
TEL 0422-47-5511
Email sukohno@ks.kyorin-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunao Kogashiwa
Organization Kyorin University
Division name Department of Otolaryngology
Zip code
Address 6-20-2, Shinkawa , Mitaka, Tokyo
TEL 0422-47-5511
Homepage URL
Email y-kogashiwa@ks.kyorin-u.ac.jp

Sponsor
Institute Kyorin University School of Medicine, Department of Otolaryngology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Saitama Medical University International Medical Center
Tokyo Medial University Hchioji Medical Center
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 杏林大学病院
埼玉医科大学国際医療センター
東京医科大学八王子医療センター

Other administrative information
Date of disclosure of the study information
2013 Year 11 Month 18 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
2013 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 19 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
2013 Year 10 Month 18 Day
Last modified on
2013 Year 10 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014113

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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