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

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 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


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

Value
https://center6.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