UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016619 |
|---|---|
| Receipt number | R000019293 |
| Scientific Title | A Feasibility Study of Gemcitabin and Bevacizumab in patients with Platinum-Resistant Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| Date of disclosure of the study information | 2015/03/01 |
| Last modified on | 2016/11/15 10:28:26 |
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Basic information
Public title
A Feasibility Study of Gemcitabin and Bevacizumab in patients with Platinum-Resistant Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Acronym
G-Bev study
Scientific Title
A Feasibility Study of Gemcitabin and Bevacizumab in patients with Platinum-Resistant Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Scientific Title:Acronym
G-Bev study
Region
| Japan |
Condition
Condition
Platinum-Resistant Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine safety and efficacy of combination chemotherapy with Gemcitabin and Bevacizumab in platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the completion rate of three cycles of chemotherapy
Key secondary outcomes
Progression free survival
Overall survival
Response rate
Dose-limiting toxicity
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
Gemcitabin+Bevacizumab
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patient with platinum-free interval equal or less than 6 months
Patient with histologically confirmed epithelial ovarian , primary peritoneal, or fallopian tube cancer
Patient with radiologically or physically confirmed recurrent cancer
Patient received equal or less than 2 regimens of chemotherapy
Patient with ECOG Performance Status 0 to 2
Patient with adequate major organ function
All patients gave written informed consent
Key exclusion criteria
Patient with active concurrent malignant disease
Patient with previous malignant disease
Patient previously recieved Gemcitabin or Bevacizumab
Patient with serious medical condition
Patient with uncontrolled hypertension
Patient with severe proteinuria
Patient with prior radiotherapy to the pelvis or abdomen
Patient with a history of bowel obstruction, abdominal fistula, GI perforation, or hemoptysis
Patient with massive pleural effusion or ascites
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoji Nagao |
Organization
Hyogo cancer center
Division name
gynecologic oncology
Zip code
Address
13-70, Kitaoji-cho, Akasi-city
TEL
078-929-1151
nagao@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ai Kogiku |
Organization
Hyogo cancer center
Division name
gynecologic oncology
Zip code
Address
13-70, Kitaoji-cho, Akasi-city
TEL
078-929-1151
Homepage URL
a.kogiku@hyogo-cc.jp
Sponsor or person
Institute
Hyogo cancer center
Institute
Department
Personal name
Funding Source
Organization
Hyogo cancer center
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
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
兵庫県立がんセンター(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2015 | 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
| 2015 | Year | 01 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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
| 2015 | Year | 02 | Month | 24 | Day |
Last modified on
| 2016 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
