UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016087 |
|---|---|
| Receipt number | R000017750 |
| Scientific Title | Efficasy and safety of bevacizumab in combination with chemotherapy for treating the first recurrence of ovarian carcinoma : Phase 2 study |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2017/07/14 18:58:39 |
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Basic information
Public title
Efficasy and safety of bevacizumab in combination with chemotherapy for treating the first recurrence of ovarian carcinoma : Phase 2 study
Acronym
Efficasy and safety of bevacizumab in combination with chemotherapy for treating the first recurrence of ovarian carcinoma : Phase 2 study
Scientific Title
Efficasy and safety of bevacizumab in combination with chemotherapy for treating the first recurrence of ovarian carcinoma : Phase 2 study
Scientific Title:Acronym
Efficasy and safety of bevacizumab in combination with chemotherapy for treating the first recurrence of ovarian carcinoma : Phase 2 study
Region
| Japan |
Condition
Condition
recurrent ovarian caricinoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
we examine the efficacy and safety of chemotherapy combined with bevacizumab for the first recurrent ovarian cancer after the frontline therapy(surgery and chemotherapy) ,including during maintenance therapy of bevacizumab
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
progression free survival
Key secondary outcomes
Adverse event of bevacizumab
response rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
10
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
study duration: 2014.11-2019.10
chemotherapy rejimenn:
PTX+CBDCA+Bev
Administration Period:until PD
Interventions/Control_2
Doc+CBDCA+Bev
Interventions/Control_3
GEM+CBDCA+Bev
Interventions/Control_4
PLD+CBDCA+Bev
Interventions/Control_5
Irinotecan+CDDP+Bev
Interventions/Control_6
PTX+Bev
Interventions/Control_7
Doc+Bev
Interventions/Control_8
GEM+Bev
Interventions/Control_9
PLD+Bev
Interventions/Control_10
Irinotecan+Bev
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
(1) histological, cytological diagnosed epithelial ovarian cancer,primary fallopian tube cancer,peritoneal cancer
(2)has performed simple hysterectomy+bilateral salpingo-oophorectomy +p-omentectomy
(3)after front line therapy and has obtained CR(including during mentainance therapy of bevacizumab),has relapsed at first
(4)chemoterapy rejimen before this treatment is until 3 rejimen
(5)PS 0-1
(6)measurable lesion of the criteria of RECIST,or/and non-mesurable lesion of cancerous ascites and pleural effusion
(7)has held patients function of major organs(such as bone marrow/hear/liver/kidney)
(8)expected survibal >3 months
(9)has obtained informed consent
Key exclusion criteria
(1)Patients with serious complications(such as uncontrolled diabetes)
(2)Patients with below such severe heart disease
congestive heart failure
uncontrolled arrhythmia
uncontrolled hypertension
angina pectoris
valvular heart disease
(3)Patients with abdominal fistula of history, gastrointestinal perforation, intra-abdominal abscess,the symptoms of intestinal obstruction
can not been able oral nutrition
not-healing wounds, ulcers,fractions
bleeding diathesis and significant
coagulopathy
Period of up to study treatment start from major surgery effective date is in the next 28 days,it is in the urine protein +2 or more at the time and registration
(4) Patients with interstitial pneumonia or pulmonary fibrosis
(5)patients with a history of severe drug hypersensitivity and drug allergy
(6)Other, patients attending physician has determined that inadequate to safely carry out the present study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Matsunaga |
Organization
Yokohama city univesity
Division name
Obstetrics and Gynecology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama-city
TEL
045-787-2800
tyamatsu@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsuya Matsunaga |
Organization
Yokohama city univesity
Division name
Obstetrics and Gynecology
Zip code
Address
Fukuura 3-9, Kanazawa-ku, Yokohama-city
TEL
045-787-2800
Homepage URL
tyamatsu@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama city univesity Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
Yokohama city univesity Obstetrics and Gynecology
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2014 | Year | 12 | Month | 30 | Day |
Last modified on
| 2017 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017750
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