UMIN-CTR Clinical Trial

Public title

Phase II multicenter trial of platinum-cetuximab combined with docetaxel or with 5FU for Japanese patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

Acronym

TEMPER study

Scientific Title

Phase II multicenter trial of platinum-cetuximab combined with docetaxel or with 5FU for Japanese patients with recurrent/metastatic squamous cell carcinoma of the head and neck.

Scientific Title:Acronym

TEMPER study

Region

Japan

Condition

recurrent/metastatic squamous cell carcinoma of the head and neck

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of modified TPEx regimen versus modified PFE regimen as a first-line treatment in recurrent/metastatic HNSCC

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

progression-free survival

Key secondary outcomes

objective responce rate
adverse events
overall survival

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

Institution consideration

Blocking

NO

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Arm A: modified PFE
Cisplatin 75 mg/m2/day1/every 3 weeks
5FU 750 mg/m2/day1-5/every 3 weeks
up to 6 cycle
Cetuximab loading dose 400mg/m2/day1, followed by 250mg/m2/week, until disease progression

Interventions/Control_2

Arm B: modified TPEx
Cisplatin 60 mg/m2/day1/every 3 weeks
Docetaxel 60mg/m2/day1/every 3weeks
up to 4 cycle
Cetuximab loading dose 400mg/m2/day1, followed by 250mg/m2/week, until disease progression

Primary prophylactic administration of GCSF must be administered systematically after each cycle of chemotherapy

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

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically confirmed recurrent or metastatic squamous cell carcinoma of head and neck (excluding nasopharynx and salivary grand)
2) Obtained tumoral tissues from oropharyngeal carcinoma patients at baseline for p16 status
3) At least one bidimensionally measurable lesion (RECIST ver.1.1) by computed tomography (CT) or magnetic resonance imaging (MRI) within 28 days from date of registration
4) ECOG performance status (PS) of 0 or 1
5) Aged 20 years or more
6) Aequate organ functions
Neutrophil >= 1,500/mm3
Platelet >= 100,000/mm3
Hemoglobin >= 9.0g/dL
T-bilirubin <= 2.4 mg/dL
Creatinin clearance >= 60 mL/min
AST or ALT <= 100U/L
7) Life expectancy of greater than 3 months
8) Women of child-bearing potential and men who are able to father a child agree with using adequate contraception
9) Written informed consent

Key exclusion criteria

1) Prior systemic chemotherapy (expect as part of a multimodal therapy for locally advaneced disease > 6 months before the trial entry)
2) Prior dose of cisplatin > 300 mg/m2
3) Prior surgery (excluding prior diagnostic biopsy) or irradiation within 4 weeks before registration
4) Simultaneous or metachronous (within 3 years) double cancers (excluding superficial cancer that will be cured by endoscopic mucosal resection)
5) Symptomatic brain metastasis
6) Severe myelosuppression or infections
7) Pulmonary fibrosis, acute lung injury or Intestinal pneumonia
8) Severe and uncontrolled complication (heart failure, pulmonary fibrosis, renal failure, hepatic failure, uncontrolle diabetes mellitus or uncontrolled hypertension)
9) Known hypersensitivity against any components of the trial treatment including excepients
10) Pregnancy or breast feeding
11) Receiving other concomitant anti tumor therapy
12) Previous treatment with cetuximab or monoclonal antibody
13) Positive HBs antigen
14) Decision of ineligibility by a physician

Target sample size

180

Name of lead principal investigator

1st name	Hidenori
Middle name
Last name	Inohara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Otorhinolaryngology - Head and Neck Surgery

Zip code

5650871

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3951

Email

hinohara@ent.med.osaka-u.ac.jp

Name of contact person

1st name	Motoyuki
Middle name
Last name	Suzuki

Organization

TEMPER study Coordinating Office

Division name

Department of Otorhinolaryngology-Head & Neck Surgery, Osaka University Graduate School of Medicine

Zip code

5650871

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3951

Homepage URL

Email

msuzuki@ent.med.osaka-u.ac.jp

Institute

Clinical Research Support Center Kyushu

Institute

Department

Personal name

Organization

Merck Serono Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Clinical Reserch Network Fukuoka Certified Review Board

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka , Fukuoka

Tel

092-643-7171

Email

mail@crnfukuoka.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学　耳鼻咽喉科・頭頸部外科(大阪府）
北海道大学　耳鼻咽喉科・頭頸部外科(北海道）
岩手医科大学医学部　頭頸部外科学科(岩手県）
東北大学　耳鼻咽喉・頭頸部外科（宮城県）
埼玉医科大学　国際医療センター頭頸部腫瘍科・耳鼻咽喉科(埼玉県）
東京大学医学部附属病院　耳鼻咽喉科（東京都）
東京慈恵会医科大学　耳鼻咽喉科（東京都）
名古屋大学　耳鼻咽喉科(愛知県）
新潟大学　耳鼻咽喉科・頭頸部外科（新潟県）
金沢大学　耳鼻咽喉科・頭頸部外科(石川県）
京都大学　耳鼻咽喉科・頭頸部外科(京都府）
香川大学　耳鼻咽喉科(香川県）
琉球大学大学院医学研究科　耳鼻咽喉・頭頸部外科学講座(沖縄県）
大阪国際がんセンター 耳鼻咽喉科（大阪府）
大阪府立急性期・総合医療センター　耳鼻咽喉・頭頸部外科（大阪府）
大阪労災病院　耳鼻咽喉科・頭頸部外科（大阪府）
徳島大学　耳鼻咽喉科（徳島県）
兵庫医科大学　耳鼻咽喉科・頭頸部外科(兵庫県）
横浜市立大学　耳鼻咽喉科・頭頸部外科（神奈川県）
東海大学病院　耳鼻咽喉科（神奈川県）
愛知医科大学　耳鼻咽喉科（愛知県）
奈良県立医科大学　耳鼻咽喉・頭頸部外科(奈良県）
久留米大学　耳鼻咽喉科・頭頸部外科（福岡県）
九州大学　耳鼻咽喉科(福岡県）
京都府立医科大学　耳鼻咽喉科・頭頸部外科(京都府）
恵佑会　札幌病院　耳鼻咽喉科・頭頸外科（北海道）
関西医科大学　耳鼻咽喉科・頭頸外科（大阪府）
金沢医科大学病院　頭頸部甲状腺外科（石川県）
国立研究開発法人国立がん研究センター中央病院　頭頸部内科（東京都）
大阪医科大学附属病院　耳鼻咽喉科・頭頸部外科（大阪府）
浜松医科大学医学部附属病院　耳鼻咽喉科・頭頚部外科学教室（静岡県）
福井大学医学部附属病院　耳鼻咽喉科・頭頸部外科（福井県）
福島県立医科大学附属病院　耳鼻咽喉科・頭頸部外科（福島県）
和歌山県立医科大学附属病院　耳鼻咽喉科・頭頸部外科（和歌山県）

Date of disclosure of the study information

2017

Year

03

Month

01

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

Open public recruiting

Date of protocol fixation

2016

Year

12

Month

22

Day

Date of IRB

2017

Year

05

Month

11

Day

Anticipated trial start date

2017

Year

10

Month

01

Day

Last follow-up date

2020

Year

10

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

12

Month

27

Day

Last modified on

2019

Year

07

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029258