UMIN-CTR Clinical Trial

Basic information
Public title	Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3)
Acronym	Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3)
Scientific Title	Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3)
Scientific Title:Acronym	Phase II/III Trial of Postoperative Chemoradiotherapy Comparing 3-Weekly Cisplatin with Weekly Cisplatin in High-risk Patients with Squamous Cell Carcinoma of Head and Neck (JCOG1008, HNC-Adjuvant CDDP+RT-P3)
Region	Japan

Condition
Condition	locally advanced squamous cell carcinoma of the head and neck
Classification by specialty	Hematology and clinical oncology Oto-rhino-laryngology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To test the non-inferioirity of concurrent chemoradiotherapy with weekly CDDP as compared to concurrent chemoradiotherapy with 3-weekly CDDP in overall survival for postoperative high risk patients with locally advanced squamous cell carcinoma of the head and neck
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase II,III

Assessment
Primary outcomes	overall survival (phase III), proportion of treatment completion (phase II)
Key secondary outcomes	relapse-free survival, local relapse-free survival, nutrition support free survival, adverse events, non-hospitalized treatment period during permissible treatment period, non-hospitalized treatment period during 90 days after the start of protocol treatment

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	A: Concurrent chemoradiotherapy with 3-Weekly CDDP (CDDP 100 mg/m2:day 1, 22, 43, fractionated radiation therapy: 66 Gy/33 Fr; Both 3D-CRT and IMRT are allowed.)
Interventions/Control_2	B:Concurrent chemoradiotherapy with Weekly CDDP (CDDP 40 mg/m2:day 1, 8, 15, 22, 29, 36, 43, fractionated radiation therapy: 66 Gy/33 Fr; Both 3D-CRT and IMRT are allowed.)
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 proven squamous cell carcinoma in resected specimen 2) Primary lesion located at oral cavity, oropharynx, hypopharynx, or larynx. 3) Pathological stage III, IVA or IVB (UICC 7th edition) 4) high risk of locoregional recurrence defined as fulfilling i) and/or ii) by pathological specimen after tumor resection and neck lymph node dissection i) Microscopically positive resection margin ii) Extracapsular nodal extension 5) Within 56 days from surgery. 6) No distant metastasis in computed tomography within 28 days before registration 7) Aged 20 to 75 years old 8) ECOG performance status (PS) of 0 or 1. 9) No prior radiation therapy, chemotherapy, nor hormonal therapy 10) Adequate organ functions 11) No clinically significant abnormal findings on electrocardiogram (ECG) within 28 days from the date of registration 12) Written informed consent
Key exclusion criteria	1) Simultaneous or metachronous (within 5 years) double cancers except carcinoma in situ or intramucosal tumor. 2) Active systemic infections to be treated. 3) Body temperature of 38 or more degrees Celsius 4) Women during pregnancy, possible pregnancy, or breast-feeding 5) Psychiatric disease 6) Continuous systemic steroid treatment 7) Uncontrolled diabetes mellitus 8) History of unstable angina pectoris or myocardial infarction within 6 months 9) Uncontrolled hypertension 10) Pleural effusion, pericardiac effusion, or ascites to be drained 11) Positive HBs antigen 12) Impossiblility to refrain from smoking or drinking during protocol treatment
Target sample size	260

Research contact person
Name of lead principal investigator	1st name Middle name Last name Makoto Tahara
Organization	National Cancer Center Hospital East
Division name	Division of Head and Neck Medical Oncology
Zip code
Address	6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, JAPAN
TEL	04-7133-1111
Email	matahara@east.ncc.go.jp

Public contact
Name of contact person	1st name Middle name Last name Naomi Kiyota
Organization	JCOG1008 Coordinating Office
Division name	Department of Medical Oncology and Hematology, Kobe University Hospital
Zip code
Address	7-5-2,Kusunoki-cho,Chuo-ku,Kobe,Hyogo, 650-0017,Japan
TEL	078-382-5111
Homepage URL	http://www.jcog.jp/
Email	JCOG_sir@ml.jcog.jp

Sponsor
Institute	Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
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

北海道大学病院（北海道） 岩手医科大学（岩手県） 東北大学病院（宮城県） 宮城県立がんセンター（宮城県） 福島県立医科大学附属病院（福島県） 自治医科大学（栃木県） 埼玉県立がんセンター（埼玉県） 埼玉医科大学国際医療センター（埼玉県） 国立がん研究センター東病院（千葉県） 国立がん研究センター中央病院（東京都） 国立病院機構東京医療センター（東京都） 東京医科歯科大学（東京都） 東京慈恵会医科大学附属病院（東京都） がん研究会有明病院（東京都） 東京大学医学部（東京都） 横浜市立大学附属病院（神奈川県） 東海大学医学部（神奈川県） 静岡県立静岡がんセンター（静岡県） 愛知県がんセンター中央病院（愛知県） 名古屋大学医学部（愛知県） 京都大学医学部附属病院（京都府） 近畿大学医学部（大阪府） 大阪国際がんセンター（大阪府） 神戸大学医学部（兵庫県） 兵庫県立がんセンター（兵庫県） 奈良県立医科大学（奈良県） 広島大学病院（広島県） 国立病院機構四国がんセンター（愛媛県）

Other administrative information
Date of disclosure of the study information	2012 Year 10 Month 16 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	No longer recruiting
Date of protocol fixation	2012 Year 08 Month 09 Day
Date of IRB	2012 Year 09 Month 27 Day
Anticipated trial start date	2012 Year 10 Month 16 Day
Last follow-up date	2025 Year 04 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 10 Month 16 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010182