UMIN-CTR Clinical Trial

Public title

Study on safety and efficacy of cetuximab in locally advanced, recurrent and/or metastatic oral cancer

Acronym

Safety and efficacy of cetuximab in oral cancer

Scientific Title

Study on safety and efficacy of cetuximab in locally advanced, recurrent and/or metastatic oral cancer

Scientific Title:Acronym

Safety and efficacy of cetuximab in oral cancer

Region

Japan

Condition

Oral cancer

Classification by specialty

Oral surgery

Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

The purpose of this study is to investigate the usage and safety and efficacy of cetuximab for oral cancer patients, and to contribute to the proper use.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Adverse events, 1-year progression-free survival and 1-year survival rate.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects must meet all the following criteria.
1. Malignant tumors originated from the oral cavity.
2. Confirmed that a histopathological malignant.
3. In locally advanced cases, the cases in UICC 7th edition stage III / IV, or recurrent and/or metastatic cases with not indicated for local therapy.
4. Received any of the therapies described below.
i) Radiation therapy (at least 60Gy)
ii) Some chemotherapy
5. Age at the time of registration at least 20 years of age
6. Performance status: 0-2
7. December 21, 2012 or later, the case that the treatment of cetuximab has been started.

Key exclusion criteria

Patients also applicable in one of the following are excluded as a target.
1. Cases with cetuximab treatment to December 20, 2012 or earlier.
2. Cases with complications in life prognosis in addition to oral cancer.
3. Cases with active double cancer. However, gastric cancer was cured by carcinoma in situ, or endoscopic mucosal resection that is judged to be cured with local treatment, esophageal cancer, colorectal cancer, such as pM it is not included in the activities of the overlapping cancer.
4. Other, patients principal investigator has determined to be inappropriate as a subject.

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Souichi Yanamoto

Organization

Nagasaki University

Division name

Hospital, Dentistry for Medically Compromised Patient

Zip code

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7698

Email

syana@nagasaki-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Souichi Yanamoto

Organization

Nagasaki University

Division name

Hospital, Dentistry for Medically Compromised Patient

Zip code

Address

1-7-1 Sakamoto, Nagasaki

TEL

095-819-7698

Homepage URL

Email

syana@nagasaki-u.ac.jp

Institute

Nagasaki University

Institute

Department

Personal name

Organization

Nagasaki University

Organization

Division

Category of Funding Organization

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

2015

Year

12

Month

16

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

No longer recruiting

Date of protocol fixation

2015

Year

07

Month

10

Day

Date of IRB

Anticipated trial start date

2015

Year

12

Month

18

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Case contro study on rare disease.
In later ethics committee approval until March 2016 to the jaw bone osteomyelitis patients who visited the facility,
survey of the following items.
1. Age
2. Gender
3. BMI
4. Smoking status
5. Drinking situation
6. PS (ECOG)
7. complications
8. medical history
9. allergy
10. primary site
11. histological type
12. TNM classification (UICC 7th edition)
13. case classification (locally advanced oral cancer or recurrent and/or metastatic oral cancer)
14. treatment history (surgery, radiation therapy, chemotherapy)
15. clinical examination value (up to the start of administration two weeks ago)
16. Description excimer blanking contents of the regimen (combination drug, dose, dosing interval, radiation dose, administration start date, end date of administration, administration end reason)
17. Treatment line (1st line, 2nd line, etc.)
18. cetuximab administration as a post-treatment (dose, dosing interval, the administration period)
19. effect judgment (target lesion effect judgment, non-target lesions effect judgment, new lesions, total effect)
20. outcome (outcome, the final progression-free date confirmed)
21. adverse events (adverse event name, date expression, CTCAE Grade, outcome-outcome date, and treatment related to events, causal relationship)

Registered date

2015

Year

12

Month

16

Day

Last modified on

2015

Year

12

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023349