UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001860
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hkurita@shinshu-u.ac.jp

Sponsor
Institute Chubu research group on oral cancer
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002230

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.