UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012074
Receipt number 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 18:58:34

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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 or person

Institute

Kyorin University School of Medicine, Department of Otolaryngology

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

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

Value
https://center6.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