UMIN-ICDS Clinical Trial

Public title

Phase II study of TransOral Surgery for local recurrence after radiotherapy for head and neck cancer in Japan

Acronym

TOS-J 3 trial

Scientific Title

Phase II study of TransOral Surgery for local recurrence after radiotherapy for head and neck cancer in Japan

Scientific Title:Acronym

TOS-J 3 trial

Region

Japan

Condition

Residual lesion or local recurrence after radiotherapy for head and neck cancer

Classification by specialty

Gastroenterology	Gastrointestinal surgery	Oto-rhino-laryngology
Adult

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The standard treatment for residual lesion or local recurrence after definitive radiotherapy or chemoradiotherapy for head and neck cancer is salvage surgery with laryngectomy. Safety and efficacy of transoral surgery for superficial residual lesion or local recurrence after definitive radiotherapy or chemoradiotherapy for head and neck cancer have not been established. Therefore, we will conduct a phase II study to investigate the safety and efficacy of transoral surgery for superficial residual lesion or local recurrence after definitive radiotherapy or chemoradiotherapy for head and neck cancer.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

2-year relapse-free survival rate

Key secondary outcomes

En bloc resection rate
The rate of adverse events associated with transoral surgery
2 and 5-year Overall survival rates, Relapse-free survival rates, Cause-specific survival rates, Laryngeal preservation survival rates and Laryngeal function preservation rates.
Local recurrence rate
Lymph node and distant recurrence rate
Examinations of voice, swallowing function, and pain
Comparison with data of the National registration survey of superficial head and neck cancer and TOS-J trial.

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 residual lesion or local recurrence after radiotherapy for 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

80

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients have received radical irradiation (radiation dose of 60 Gy or more) for the primary disease in the past.
2) Histologically diagnosed as squamous cell carcinoma (not including severe dysplasia).
3) Clinically diagnosed as residual lesion or local recurrence.
4) Most of the lesion is confined to the epithelium and subepithelial layer.
5) Lesions primarily located in the oropharynx, hypopharynx or supraglottic (not including cervical esophageal lesions).
6) A clinical diagnosis that the residual lesion or local recurrence is 4cm or less in diameter (rT2) (T factor before radical irradiation is not considered).
7) Neither CT nor MRI shows obvious cartilage invasion of the residual lesion or local recurrence.
8) No evidence of lymph node metastasis or distant metastasis on computed tomography of the neck, chest or abdomen (rN0M0) (Regions including the cranial base should be scanned, with a slice thickness of 10 mm or less.)
9) An age of 20 years to 75 years or younger at the time of registration.
10) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
11) All of the following conditions are met (all laboratory tests should be the most recent within 28 days prior to enrollment) Testing on the same day of the week 4 weeks prior to registration is 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
12) Written consent to participate in the study has been obtained.

Key exclusion criteria

1) Patient has two or more multiple cancers of the head and neck region other than the primary lesion at the time of enrollment.
2) Incurable multiple head and neck cancers or double cancers
3) Scheduled to receive chemotherapy (including endocrine therapy, molecular targeted therapy, or immune checkpoint inhibitors) for multiple head and neck cancers or double cancers at the time of enrollment.
4) Women who might be pregnant
5) Participation in the study is precluded by the presence of psychosis or psychiatric symptoms.
6) Active infection (a fever of >=38 degrees and bacterial infection confirmed on imaging studies or bacteriologic examinations)
7) Investigator determines that the patient is ineligible.

Target sample size

28

Name of lead principal investigator

1st name	Ryuichi
Middle name
Last name	Hayashi

Organization

National Cancer Center Hospital East

Division name

Department of Head and Neck Surgery

Zip code

277-8577

Address

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

TEL

04-7133-1111

Email

rhayashi@east.ncc.go.jp

Name of contact person

1st name	Koichi
Middle name
Last name	Kano

Organization

Kitasato University School of Medicine

Division name

Department of Otorhinolaryngology - Head and Neck Sugery

Zip code

252-0375

Address

1-15-1, Kitazato, Minami, Sagamihara, Kanagawa, Japan

TEL

042-778-8111

Homepage URL

Email

kkent@med.kitasato-u.ac.jp

Institute

National Cancer Center Hospital East

Institute

Department

Personal name

Ryuichi Hayashi

Organization

National Cancer Center Hospital East

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Kitasato University School of Medicine and Hospital

Address

1-15-1, Kitazato, Minami, Sagamihara, Kanagawa,Japan

Tel

042-778-8111

Email

rinrib@med.kitasato-u.ac.jp

Secondary IDs

YES

Study ID_1

C22-084

Org. issuing International ID_1

Institutional Review Board of Kitasato University School of Medicine and Hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

01

Month

11

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

Enrolling by invitation

Date of protocol fixation

2022

Year

11

Month

08

Day

Date of IRB

2022

Year

12

Month

22

Day

Anticipated trial start date

2023

Year

02

Month

01

Day

Last follow-up date

2031

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

01

Month

11

Day

Last modified on

2023

Year

07

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056974