UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008388 |
|---|---|
| Receipt number | 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 17:48:28 |
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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
| Obstetrics 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
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
ttakano@med.tohoku.ac.jp
Sponsor or person
Institute
Gynecology, Tohoku University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009861
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