UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000273 |
|---|---|
| Receipt number | R000000344 |
| Scientific Title | Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Phase II Study |
| Date of disclosure of the study information | 2006/03/01 |
| Last modified on | 2012/07/17 19:34:56 |
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Basic information
Public title
Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Phase II Study
Acronym
Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Phase II Study
Scientific Title
Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Phase II Study
Scientific Title:Acronym
Concurrent Chemoradiotherapy with Cisplatin and Docetaxel for Advanced Head and Neck Cancer Phase II Study
Region
| Japan |
Condition
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
Objectives
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
Assessment
Primary outcomes
Survival rate
Key secondary outcomes
Response rate, safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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 60Gy/30fractions/6weeks
Chemotherapy: weekly administration of cisplatin 20mg/m2 and docetaxel 10mg/m2, total of 6 courses
Adjuvant chemotherapy is scheduled for patients with unresectable disease.
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
Eligibility
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
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
160
Research contact person
Name of lead principal investigator
| 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
Public contact
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
TEL
Homepage URL
Sponsor or person
Institute
Department of Otolaryngology, Osaka University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2004 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 11 | Month | 01 | Day |
Last modified on
| 2012 | Year | 07 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000344
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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