UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study of gemcitabine plus docetaxel in patient with refractory bone and soft tissue sarcomas
Title of the study (Brief title)	GEM+DTX in patient with sarcomas
Region	Japan

Condition
Condition	bone and soft tissue sarcoma
Classification by specialty	Orthopedics
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Chemotherapy using Ifosfamide, doxorubicin, cisplatin, etoposide, methotrexateis provided for bone and soft tissue sarcomas conventionally. There are some clinical problems that conventional chemotherapy resist tumor, myelosupression and necessity of hospitalization. Gemcitabine and docetaxel are already approved in Japan. The efficacy of chemotherapy with gemcitabine and docetaxel as a second line for refractory bone and soft tissue sarcomas was reported. Chemotherapy with gemcitabine and docetaxel had relatively low risk for myelosupression, this treatment can be indicated in daily out patient clinic. We plan a clinical study of gemcitabine and docetaxel for patient with refractory bone and soft tissue sarcomas.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2
Developmental phase	Phase II

Assessment
Primary outcomes	tumor response survival
Key secondary outcomes

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	From June 25th, 2015 to December 31th, 2018 Gemcitabine675mg/m2, day1, day8 Docetaxel75mg/m2, day8 3 weeks or more interval
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	15 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Establishment of histopathological diagnosis of bone and soft tissue sarcomas Non responder case with previous 1st line chemotherapy Patient who had enough understanding after explanation of this study and presented document of agreement by their free will
Key exclusion criteria	Patient with severe liver or renal dysfunction Patient with severe interstitial pneumonitis PS4 Pregnant woman Patient who was decided as incompatible by the principal investigator of this study
Target sample size	10

Research contact person
Name of lead principal investigator	Torigoe Tomoaki
Organization	Juntendo University Urayasu Hospital
Division name	Orthopaedic Surgery
Address	2-1-1, Tomioka, Urayasu-city, Chiba, 279-0021
TEL	047-353-3111
Email	ttorigoe@juntendo.ac.jp

Public contact
Name of contact person	Torigoe Tomoaki
Organization	Juntendo University Urayasu Hospital
Division name	Orthopaedic Surgery
Address	2-1-1, Tomioka, Urayasu-city, Chiba, 279-0021
TEL	047-353-3111
Homepage URL
Email	ttorigoe@juntendo.ac.jp

Sponsor
Institute	Juntendo University Urayasu Hospital
Institute
Department

Funding Source
Organization	Juntendo University Urayasu Hospital
Organization
Division
Category of Funding Organization	Other
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	2015 Year 06 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 11 Day
Anticipated trial start date	2015 Year 06 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 18 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020780