UMIN-CTR Clinical Trial

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

head and neck squamous cell carcinoma

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kyorin University School of Medicine, Department of Otolaryngology

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Saitama Medical University International Medical Center
Tokyo Medial University Hchioji Medical Center

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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

Date of disclosure of the study information

2013

Year

11

Month

18

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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