UMIN-CTR Clinical Trial

Public title

Phase II and III Studies of Transoral Surgery for Superficial Head and Neck Cancer

Acronym

TOS-J trial (Phase II/III Study of Transoral Surgery for Superficial Head and Neck Cancer in Japan)

Scientific Title

Phase II and III Studies of Transoral Surgery for Superficial Head and Neck Cancer

Scientific Title:Acronym

TOS-J trial (Phase II/III Study of Transoral Surgery for Superficial Head and Neck Cancer in Japan)

Region

Japan

Condition

Superficial Head and Neck Cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The study group comprised 568 of the 599 patients (959 lesions) who were registered in the National Registration Survey of Superficial Head and Neck Cancer. The median follow-up was 46.1 months (range, 1.1 to 113.3). The overall survival rate at 3 years was 87.9%, which was considered good. Adverse events occurred in 12.2% of 768 treatment sessions, among which 0.9% were life-threatening, but there was no treatment-related death. The present intervention trial is designed to study the effectiveness and safety of transoral surgery for superficial head and neck cancer on the basis of these results. In the present study, the safety of transoral surgery will be evaluated in a phase II study. After confirming the safety of treatment, a validation phase III study will be performed.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III

Primary outcomes

Phase II study
The incidences of adverse events associated with transoral surgery for superficial head and neck cancer

Phase III study
Primary endpoint: the overall survival at 3 years in patients who undergo transoral surgery for superficial head and neck cancer

Key secondary outcomes

Phase III study
Secondary endpoints: the 3-year and 5-year distant recurrence-free survival, relapse-free survival, cause-specific survival, larynx-preservation survival, in patients who undergo transoral surgery for superficial head and neck cancer; the 5-year overall survival in patients who undergo transoral surgery for superficial head and neck cancer; the rate of local recurrence, the rate of metastatic recurrence, the incidence of multiple cancers, the incidence of double cancers, the incidences of adverse events associated with transoral surgery, the rate of larynx function preservation; examinations of voice, swallowing function, and pain; and comparison with data from the National Registration Survey of Superficial Head and Neck Cancer.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Transoral surgery for superficial head and neck cancer

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) A histologically confirmed diagnosis of squamous cell carcinoma (not including severe dysplasia)
2) A clinically confirmed diagnosis that the depth of invasion by the primary tumor does not reach the mascularis propria
3) Lesions primarily located in the oropharynx, hypopharynx or supraglottis (not including lesions that invade the cervical esophagus even if the lesion is primarily located in the hypopharynx)
4) A clinical diagnosis that the primary lesion is 4 cm or less in diameter
5) No evidence of lymph node metastasis or distant metastasis on computed tomography of the neck, chest or abdomen (cN0M0) (Regions including the cranial base should be scanned, with a slice thickness of 10 mm or less.)
6) If multiple lesions are detected at the time of registration, up to 2 accessory lesions (a total of 3 lesions including the primary lesion). The size of the accessory lesions is not specified.
7) An age of 20 years to 75 years or younger at the time of registration
8) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
9) All of the following conditions are satisfied (The most recent test data obtained within 28 days before registration are used for all examination variables. Tests performed on the same day of the week 4 weeks before the day of registration are acceptable.)
a. Leukocyte count >= 3000/uL
b. Hemoglobin level >= 10 g/dL
c. Platelet count >=100 x 103/uL
d. Aspartate aminotransferase and alanine transaminase levels 3 times or less the institutional upper limit of normal
e. Total bilirubin levels 1.5 times or less the institutional upper limit of normal
f. No electrocardiographic abnormalities requiring treatment on 12-lead electrocardiograms obtained at rest
10) Written informed consent for participation in the study is obtained.

Key exclusion criteria

1) Allergy to iodine
2) Temporary discontinuation of anticoagulant drugs or antiplatelet agents to allow transoral surgery is not possible.
3) Incurable double cancers
4) At the time of registration the patient is scheduled to undergo radiotherapy for multiple or double cancers of the head and neck.
5) At the time of registration the patient is scheduled to receive chemotherapy (including endocrine therapy, molecular targeted therapy, and immune checkpoint inhibitors) for multiple or double cancers.
6) Residual lesions after radiotherapy and chemoradiotherapy
7) Women who might be pregnant
8) Participation in the study is precluded by the presence of psychosis or psychiatric symptoms.
9) Active infection (a fever of >=38 degrees and bacterial infection confirmed on imaging studies or bacteriologic examinations)

Target sample size

130

Name of lead principal investigator

1st name
Middle name
Last name	Ryuichi Hayashi

Organization

National cancer center hospital east

Division name

Department of Head and Neck Surgery

Zip code

Address

Kashiwanoha 6-5-1, Kashiwa, Chiba 277-8577, Japan

TEL

0471-33-1111

Email

rhayashi@east.ncc.go.jp

Name of contact person

1st name
Middle name
Last name	Chikatoshi Katada

Organization

Kitasato University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

Kitasato 1-15-1, Minami, Sagamihara, Kanagawa 252-0374, Japan

TEL

042-778-8111

Homepage URL

Email

ckatada@med.kitasato-u.ac.jp

Institute

Kitasato University School of Medicine

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

03

Month

14

Day

Date of IRB

Anticipated trial start date

2017

Year

06

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

24

Day

Last modified on

2017

Year

05

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030638