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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031004
Receipt No. R000034972
Scientific Title Phase 2 study of gemcitabine and docetaxel chemotherapy for advanced bone and soft tissue sarcomas
Date of disclosure of the study information 2018/03/01
Last modified on 2018/10/19

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Basic information
Public title Phase 2 study of gemcitabine and docetaxel chemotherapy for advanced bone and soft tissue sarcomas
Acronym GD therapy for advanced sarcomas
Scientific Title Phase 2 study of gemcitabine and docetaxel chemotherapy for advanced bone and soft tissue sarcomas
Scientific Title:Acronym GD therapy for advanced sarcomas
Region
Japan

Condition
Condition advanced bone and soft tissue sarcomas
Classification by specialty
Hematology and clinical oncology Orthopedics
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate the efficacy and safety of gemcitabine and docetaxel chemotherapy for advanced bone and soft tissue sarcoma patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes progression free survival
Key secondary outcomes objective response rate, disease control rate, incidence rate of adverse event, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Gemcitabine (900 mg/m2) intravenously(IV) on Day 1 and Day 8, and docetaxel (70 mg/m2) IV on Day 8, repeated every 3 weeks until progression 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
10 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Patients are histopathologically diagnosed as the primary malignant tumor (sarcoma) of bone and soft tissue.
2)Patients with advanced bone and soft tissue sarcoma having recurrence or metastasis.
3)Patients who have previously received a standard therapy for bone and soft tissue sarcoma or could not receive a standard therapy.
4)Patients who aged 10 to 70 years old at the time of enrollment.
5)Patients who have a measurable evaluation lesion.
6)Performance status (PS) is 0 or 1 in a standard of ECOG.
7)Patients who have a primary tumor that appeared in extremity or trunk.
8)Laboratory data within 14 days prior to enrollment meet all of the followings:
1.Neutrophil more than 1,500 /mm3
2.Hemoglobin more than 8.0 g/dL (there is no blood transfusion within 14 days)
3.Platelet more than 100,000/mm3
4.Total bilirubin less than 1.5 mg/dL
5.AST(GOT) less than 100IU/L
6.ALT(GPT) less than 100IU/L
7.Creatinine less than 1.5 mg/dL
8.Creatinine clearance (eGFR) more than 60 mL/min
9)normal electrocardiogram within 28 days prior to enrollment
10)Patients without interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema.
11)Patients were given a written explanation of the study protocol and provided their written informed consent.
Key exclusion criteria 1)Active double cancers within 5 years(cured intraepithelial carcinoma and intramucosal carcinoma are not included)
2)Cases with complications of severe infection
3)Body temperature more than 38 degree
4)Pregnant or breastfeeding women
5)Severe psychological disease
6)
7)Unstable angina (within 3 months after onset) , myocardial infarction
8)Difficult-to-control hypertension
9)Difficult-to-control diabetes
10)HBs antigen is positive
11)Judgment to attending physician
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitomi Hara
Organization Kobe University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5985
Email mitohi@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Hara
Organization Kobe University Graduate School of Medicine
Division name Department of Orthopaedic Surgery
Zip code
Address 7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL 078-382-5985
Homepage URL
Email mitohi@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
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
2018 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 Open public recruiting
Date of protocol fixation
2018 Year 01 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 01 Month 25 Day
Last modified on
2018 Year 10 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034972

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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