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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008388
Receipt No. R000009861
Scientific Title The feasibility study of gemcitabine plus docetaxel in advanced uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan.
Date of disclosure of the study information 2012/07/09
Last modified on 2012/07/09

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Basic information
Public title The feasibility study of gemcitabine plus docetaxel in advanced uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan.
Acronym GD combination chemotherapy for LMS/UES
Scientific Title The feasibility study of gemcitabine plus docetaxel in advanced uterine leiomyosarcoma and undifferentiated endometrial sarcoma in Japan.
Scientific Title:Acronym GD combination chemotherapy for LMS/UES
Region
Japan

Condition
Condition Leiomyosarcoma and undifferentiated endometrial sarcoma of the uterus
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To determine activity of gemcitabine plus docetaxel in advanced Japanese LMS/UES
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Progression free survival, Overall survival, Adverse events

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Eligible women with advanced LMS were treated with gemcitabine 900 mg/m2 over 90-minute infusion, on days one and eight, plus docetaxel 70 mg/m2 on day eight, every 3 weeks, without granulocyte colony-stimulating factor (G-CSF). No patients with prior pelvic radiation received. In this feasibility study, the primary end point was tumor response, defined as complete or partial response or stable disease. Patients were treated until disease progression, unacceptable toxicity or at the discretion of the investigator.
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

Not applicable
Gender Female
Key inclusion criteria Women with advanced or recurrent LMS/UES who had progressed after treatment with one or two prior cytotoxic regimen, and who had measurable disease that was not considered respectable, were eligible.
All tumors were histologically confirmed.
Prior therapy with gemcitabine or docetaxel was not permitted.
Patients were permitted to have had prior pelvic radiotherapy.
Patients were required to have ECOG performance status of 0-2, and adequate bone marrow function (absolute neutrophil count (ANC) greater than or equal to 1500/microlitter, and platelets greater than or equal to 100,000/microlitter); renal function (creatinine less than or equal to 1.5 X the institutional upper limit of normal); hepatic function (bilirubin less than or equal to 1.5 X the institutional upper limit of normal, and Serum glutamic oxaloacetic transaminase (SGOT) and alkaline phosphatase less than or equal to 2.5 X the institutional upper limit of normal); and neurologic function (baseline neuropathy, sensory and motor, less than or equal to Common Toxicity Criteria grade 1).
All patients signed written, informed consent. The protocol and consent were reviewed and approved annually by participating institutions' Institutional Review Boards.
Key exclusion criteria Patients with a history of other invasive malignancy within the past 5 years were not eligible.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuo Yaegashi
Organization Tohoku University Hospital
Division name Gynecology
Zip code
Address 1-1 Seiryo-machi, Aoba ward, Sendai, Miyagi, 9808574, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadao Takano
Organization Tohoku University Hospital
Division name Gynecology
Zip code
Address
TEL
Homepage URL
Email ttakano@med.tohoku.ac.jp

Sponsor
Institute Gynecology, Tohoku University Hospital
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology, and by a grant-in-aid from the Ministry of Health, Labor and Welfare, Japan.
Organization
Division
Category of Funding Organization
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
2012 Year 07 Month 09 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 Completed
Date of protocol fixation
2004 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2004 Year 08 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
2012 Year 07 Month 01 Day
Date trial data considered complete
2012 Year 07 Month 01 Day
Date analysis concluded
2012 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 09 Day
Last modified on
2012 Year 07 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009861

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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