UMIN-CTR Clinical Trial

Public title

Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-

Acronym

Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-

Scientific Title

Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-

Scientific Title:Acronym

Feasibility study of concurrent chemoradiotherapy with docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction -Multicenter study-

Region

Japan

Condition

head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the possibility of concurrent chemoradiotherapy with low-dose weekly docetaxel and cisplatin for head and neck cancer in the elderly or mild renal dysfunction

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Phase I

Primary outcomes

Completion rate, safety

Key secondary outcomes

Adverse event rate
treatment response rate
2-year overall survival rate
2-year disease specific survival rate
2-year disease free survival rate

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Historical

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Concurrent chemoradiotherapy
Radiotherapy: 2Gy/fraction/day, 5fractions/week, total dose of 66Gy/33fractions/7weeks
Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses

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) no tumor-specific pretreatment
2) no prior radiation against the same field as currently scheduled
3) estimable or measurable lesion
4) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
5) expected survival duration for > 3months after the biginning of the treatment
6) no major impairment of liver, kidney, or bone marrow, fulfilling the condition of AST/ALT <2times the upper limit of normal, BUN <25mg/dl, serum creatinine <1.5mg/dl, creatinine clearance >=40ml/min(age 76-80 yeas old), 60ml/min >creatinine clearance >=40ml/min(age 20-75 yeas old), white blood cell count >4000/mm3, neutrophil count >2000/mm3, and platelet count >100,000/mm3
7) no evidence of active infection or fever >38C
8) written informed consent

Key exclusion criteria

1) interstitial pneumonia or pulmonary fibrosis evidenced by chest X-ray and/or chest CT
2) major heart/lung disorders, or uncontrolled diabetes mellitus
3) distant metastases or second primary cancer except when there has been no evidence of the disease for more than 24 months without any treatment
4) major pulmonary effusion or ascites
5) neuropathy or edema
6) pregnancy or lactation
7) history of major allergy to medicine
8) long use of steroid

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Hidenori Inohara

Organization

Osaka University School of Medicine

Division name

Department of Otolaryngology-Head and Neck Surgery

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3951

Email

hinohara@ent.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Norihiko Takemoto

Organization

Osaka University School of Medicine

Division name

Department of Otolaryngology-Head and Neck Surgery

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3951

Homepage URL

http://www.med.osaka-u.ac.jp/pub/ent/index.html

Email

ntakemoto@ent.med.osaka-u.ac.jp

Institute

Department of Otolaryngology-Head and Neck Surgery, Osaka University School of Medicine

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

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

2012

Year

11

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

Open public recruiting

Date of protocol fixation

2012

Year

11

Month

06

Day

Date of IRB

Anticipated trial start date

2012

Year

11

Month

11

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

11

Month

06

Day

Last modified on

2016

Year

03

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010890