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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011497
Receipt No. R000013418
Scientific Title Phase II trial of Nedaplatin/S-1/Cetuximab combination therapy for Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Date of disclosure of the study information 2013/08/16
Last modified on 2014/09/06

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Basic information
Public title Phase II trial of Nedaplatin/S-1/Cetuximab combination therapy for Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Acronym Phase II trial of Nedaplatin/S-1/Cetuximab combination therapy for Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Scientific Title Phase II trial of Nedaplatin/S-1/Cetuximab combination therapy for Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Scientific Title:Acronym Phase II trial of Nedaplatin/S-1/Cetuximab combination therapy for Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Region
Japan

Condition
Condition Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Classification by specialty
Medicine in general Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluating the efficacy and safety of Nedaplatin/S-1/Cetuximab combination therapy for Recurrence or Metastatic Squamous cell carcinoma of the Head and Neck
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes Adverse event, proportion of treatment completion, progression-free survival, overall survival, clinical utility

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 Nedaplatin+S-1+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

Not applicable
Gender Male and Female
Key inclusion criteria Histologically diagnosed primary squamous cell carcinoma

Primary lesion located in the oral, nasopharynx, mesopharynx, hypopharynx, or larynx

Measurable disease according to RECIST ver1.1

Age older than 20

ECOG PS 0 or 1

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 Prior systemic chemotherapy or radiotherapy which was completed more than 2 weeks prior to registration

Current administration of Flucytosine

Treated continuously with systemic steroids

With history of severe drug allergy

Massive pleural or pericardial effusion, ascites

Known coronary artery disease, history of myocardial infarction within prior 6 Prior systemic chemotherapy or radiotherapy which was completed more than 2 weeks prior to registration

Current administration of Flucytosine

Treated continuously with systemic steroids

With history of severe drug allergy

Massive pleural or pericardial effusion, ascites

Known coronary artery disease, history of myocardial infarction within prior 6 months or uncontrollable hypertension

known cerebrovasucular disease within 6 months

Active infection

Continuous diarrhea

Ileus or sub-ileus

History of multiple cancers unless free of disease for at least five years

Severe diabetes

Positivity for hepatitis B surface antigen

Severe psychotic disorder

Pregnancy or breast feeding

Other significant disease that in the investigator's opinion would exclude the subject from the trial
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiko Nakagawa
Organization Kinki University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-1,Ohnohigasi, Osakasayama-city, Osaka
TEL 072-366-0221
Email nakagawa@med.kindai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takayuki Takahama, Kaoru Tanaka
Organization Kinki University Faculty of Medicine
Division name Department of Medical Oncology
Zip code
Address 377-1,Ohnohigasi, Osakasayama-city, Osaka
TEL 072-366-0221
Homepage URL
Email takahama_t@dotd.med.kindai.ac.jp

Sponsor
Institute Kinki University Faculty of Medicine,
Department of Medical Oncology
Institute
Department

Funding Source
Organization none
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 近畿大学医学部附属病院(大阪府)、近畿大学医学部付属奈良病院(奈良県)、市立岸和田市民病院(大阪府)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 16 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 Open public recruiting
Date of protocol fixation
2013 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 08 Month 08 Day
Last follow-up date
2015 Year 08 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
2013 Year 08 Month 16 Day
Last modified on
2014 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013418

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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