UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031004 |
|---|---|
| Receipt number | 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 | 2023/01/30 12:10:00 |
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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 | Hitomi |
| Middle name | |
| Last name | Hara |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5985
mitohi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Hara |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
6500017
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5985
Homepage URL
mitohi@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
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
Kobe University Clinical Research Ethical Committee
Address
7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-6669
kainyu@med.kobe-u.ac.jp
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
神戸大学医学部附属病院
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
| 2018 | Year | 12 | Month | 03 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2028 | Year | 01 | Month | 31 | Day |
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
| 2023 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034972
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