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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009125
Receipt No. R000010182
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)
Date of disclosure of the study information 2012/10/16
Last modified on 2017/11/21

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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 Open public recruiting
Date of protocol fixation
2012 Year 08 Month 09 Day
Date of IRB
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
2017 Year 11 Month 21 Day


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

Research Plan
Registered date File name

Research case data specifications
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Research case data
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