UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001860 |
|---|---|
| Receipt number | R000002230 |
| Scientific Title | Multicenter phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma |
| Date of disclosure of the study information | 2009/04/08 |
| Last modified on | 2017/04/17 07:33:50 |
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Basic information
Public title
Multicenter phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma
Acronym
Phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral cancer
Scientific Title
Multicenter phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma
Scientific Title:Acronym
Phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral cancer
Region
| Japan |
Condition
Condition
Oral squamous cell carcinoma
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety dose of outpatient chemotherapy with docetaxel and nedaplatin for patients with unresectable or recurrent oral squamous cell carcinoma
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Safety of outpatient chemotherapy with docetaxel and nedaplatin for patients with unresectable or recurrent oral squamous cell carcinoma
Key secondary outcomes
Clinical and histopathological effect of outpatient chemotherapy with docetaxel and nedaplatin for patients with unresectable or recurrent oral squamous cell carcinoma
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Docetaxel is administered intravenously for 1 h on day1. After completion of the docetaxel infusion, nedaplatin is administered intravenously for another hour followed by 1,000 ml or more hydration. The dose levels of biweekly chemotherapy with docetaxel and nedaplatin are 30/40, 30/50, and 35/50 (mg/m2).
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Case with oral squamous cell carcinoma histologically, (2) age between 20 and 80 years (patients aged >80 years were allowed if major organs functions was preserved), (3) Karnofsky Performance Status (PS) score of 2 or less (4) adequate bone marrow function (5) adequate hepatic function (6) adequate renal function (7) written informed consent.
Key exclusion criteria
Patients were excluded if they had active infections, active second malignancy, severe heart diseases, interstitial pneumonia or lung fibrosis, severe pleural effusion or pericardial effusion that required drainage, fever more than or equal to 38 C, symptomatic brain metastasis, severe psychological disease, and possible pregnancy.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuhide Yamamoto |
Organization
Kanazawa University Graduate School of Medical Science
Division name
Oral & Maxillofacial Surgery
Zip code
Address
13-1 Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2444
hkurita@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kurita |
Organization
Shinshu University School of Medicine
Division name
Department of Dentistry and Oral surgery
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2675
Homepage URL
hkurita@shinshu-u.ac.jp
Sponsor or person
Institute
Chubu research group on oral cancer
Institute
Department
Personal name
Funding Source
Organization
Chubu research group on oral cancer
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
| 2009 | Year | 04 | Month | 08 | 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
| 2008 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2014 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 04 | Month | 08 | Day |
Last modified on
| 2017 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002230
