UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030098 |
|---|---|
| Receipt number | 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 | 2022/12/13 11:25:52 |
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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
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/
JCOG_sir@ml.jcog.jp
Sponsor or person
Institute
Japan Clinical Oncology Group (JCOG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034135
