UMIN-CTR Clinical Trial

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