UMIN-CTR Clinical Trial

Public title

Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study

Acronym

Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study

Scientific Title

Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study

Scientific Title:Acronym

Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Multicentric Phase II Study

Region

Japan

Condition

Head and neck squamous cell carcinoma at stage III and IV

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To assess the efficacy and safety of weekly administration of cisplatin and docetaxel concurrently combined with conventional radiotherapy

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Response rate

Key secondary outcomes

Survival rate, organ preservation rate, safety

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 60-70Gy/30-35fractions for non-nasopharyngeal cancer, or 1.8Gy/fraction/day, 5fractions/week, total dose of 70.2Gy/39fractions for nasopharyngeal cancer
Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses
Adjuvant chemotherapy of 2 or more than 2 courses of TPF (CDDP+DOC+5-FU) is scheduled for technically unresectable cases.

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) 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 or 1
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 >60ml/min, 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 and when the disease is superficial
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

150

Name of lead principal investigator

1st name
Middle name
Last name	Hidenori Inohara

Organization

Osaka University School of Medicine

Division name

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-5056

Email

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

Name of contact person

1st name
Middle name
Last name	Hidenori Inohara

Organization

Osaka University School of Medicine

Division name

Department of Otolaryngology

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-5056

Homepage URL

Email

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

Institute

Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine

Institute

Department

Personal name

Organization

Department of Otorhinolaryngology and Head and Neck Surgery, Osaka University School of Medicine

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

2006

Year

03

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

CR rate 71%, 2-year overall survival 82%, and 4-year overall survival 68% for technically resectable disease.
CR rate 45%, 2-year overall survival 58%, and 4-year overall survival 44% for technically unresectable disease.

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

Completed

Date of protocol fixation

2004

Year

03

Month

04

Day

Date of IRB

Anticipated trial start date

2006

Year

01

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

2006

Year

01

Month

17

Day

Last modified on

2014

Year

12

Month

26

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000394