UMIN-CTR Clinical Trial

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	2017 Year 09 Month 26 Day
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	2022 Year 12 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034135