UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011497 |
|---|---|
| Receipt number | 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 09:15:48 |
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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
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
takahama_t@dotd.med.kindai.ac.jp
Sponsor or person
Institute
Kinki University Faculty of Medicine,
Department of Medical Oncology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013418
