UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025436
Receipt No. R000029258
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.
Date of disclosure of the study information 2017/03/01
Last modified on 2019/07/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
Condition recurrent/metastatic squamous cell carcinoma of the head and neck
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
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

Assessment
Primary outcomes progression-free survival
Key secondary outcomes objective responce rate
adverse events
overall survival

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Clinical Research Support Center Kyushu
Institute
Department

Funding Source
Organization Merck Serono Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2017 Year 03 Month 01 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
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
Other related information

Management information
Registered date
2016 Year 12 Month 27 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029258

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.