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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030098
Receipt No. R000034135
Scientific Title Randomized phase III study to evaluate the value of omission of prophylactic neck dissection for stage I/II tongue cancer (JCOG1601, RESPOND)
Date of disclosure of the study information 2017/11/24
Last modified on 2017/11/24

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Basic information
Public title Randomized phase III study to evaluate the value of omission of prophylactic neck dissection for stage I/II tongue cancer (JCOG1601, RESPOND)
Acronym Randomized phase III study to evaluate the value of omission of prophylactic neck dissection for stage I/II tongue cancer (JCOG1601, RESPOND)
Scientific Title Randomized phase III study to evaluate the value of omission of prophylactic neck dissection for stage I/II tongue cancer (JCOG1601, RESPOND)
Scientific Title:Acronym Randomized phase III study to evaluate the value of omission of prophylactic neck dissection for stage I/II tongue cancer (JCOG1601, RESPOND)
Region
Japan

Condition
Condition clinical stage I/II (T1-2N0) tongue cancer
Classification by specialty
Hematology and clinical oncology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To confirm the non-inferiority of partial glossectomy alone to partial glossectomy with prophylactic neck dissection in terms of OS for clinical stage I-II (T1-2N0) tongue cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival
Key secondary outcomes Relapse-free survival, Local-relapse-free survival, Proportion of unresectable relapse, Proportion of cervical-lymph node relapse, Postoperative function (paralysis of the accessory nerve and the mandibular branch of the facial nerve, subjective symptoms), Adverse events

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
Maneuver
Interventions/Control_1 A: partial glossectomy with prophylactic neck dissection
Interventions/Control_2 B: partial glossectomy alone
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
80 years-old >=
Gender Male and Female
Key inclusion criteria 1)Histologically proven squamous cell carcinoma by biopsy specimen of the tongue
2)Clinically diagnosed as Stage I/II (T1-2, N0, M0) tongue carcinoma (UICC-TNM 8th edition)
i)The maximum of tumor diameter is 4 cm or less by enhanced computed tomography and clinical findings.
ii)No lymph node metastases by enhanced computed tomography of neck
iii)No distant metastases by enhanced computed tomography of chest and upper abdomen
3)DOI of tumor spread from 3 mm to 10 mm by enhanced magnetic resonance imaging
4)Age >= 20 and =< 80
5)Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
6)No history of tongue carcinoma
7)No previous cervical lymph node resection or radiotherapy to the neck
8)No preoperative therapy for tongue carcinoma
9)No previous chemotherapy or radiotherapy for any malignant neoplasms.
10)Adequate organ and marrow function as defined below within 28 days prior to registration:a) White blood cell >= 3,000 /mm3
b) Hemoglobin >= 8.0 g/dL
c) Platelets >= 75,000 /mm3
d) Total bilirubin =< 2.0 mg/dL
e) AST=< 100 IU/L
f) ALT=< 100 IU/L
g) Creatinine =< 1.5 mg/dL
11)No abnormal findings requiring treatment on electrocardiogram (ECG) within 28 days prior to registration
12)Written informed consent
Key exclusion criteria 1)Synchronous or metachronous (within 5 years) malignancy except cancer with 5-year relative survival rate of 95% or more such as carcinoma in situ, intramucosal tumor, or early stage cancers.
2)Active infection requiring systemic therapy
3)Body temperature >= 38 degrees Celsius
4)Women during pregnancy, within 28 days of postparturition, or during lactation. Men favoring gestation of their partners.
5)Severe psychiatric disease
6)Patients requiring systemic steroid medication or the other immunosuppressive drug excluding corticosteroid drugs.
Target sample size 440

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryuichi Hayashi, MD, PhD
Organization National Cancer Center Hospital East, Japan
Division name Department of Head and Neck Surgery
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa-city, Chiba, 277-8577, Japan
TEL 04-7133-1111
Email rhayashi@east.ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Hanai, MD, PhD
Organization JCOG1601 Coordinating Office
Division name Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Japan
Zip code
Address 1-1, Kanokoden, Chikusa-ku, Nagoya-city, Aichi, 464-0008, Japan
TEL 052-762-6111
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group (JCOG)
Institute
Department

Funding Source
Organization National Cancer Center
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
2017 Year 11 Month 24 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
2017 Year 09 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 24 Day
Last follow-up date
2029 Year 05 Month 24 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 24 Day
Last modified on
2017 Year 11 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034135

Research Plan
Registered date File name

Research case data specifications
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Research case data
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