UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter phase I trial of outpatient chemotherapy with docetaxel and nedaplatin for oral squamous cell carcinoma
Title of the study (Brief title)	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	Etsuhide Yamamoto
Organization	Kanazawa University Graduate School of Medical Science
Division name	Oral & Maxillofacial Surgery
Address	13-1 Takaramachi, Kanazawa, Ishikawa
TEL	076-265-2444
Email	hkurita@shinshu-u.ac.jp

Public contact
Name of contact person	Hiroshi Kurita
Organization	Shinshu University School of Medicine
Division name	Department of Dentistry and Oral surgery
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2008 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000002230