UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024137 |
|---|---|
| Receipt number | R000027794 |
| Scientific Title | Phase II study of combination chemotherapy using paclitaxel, carboplatin, and bevacizumab in patients with advanced or recurrent cervical cancer. |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2016/09/23 15:03:20 |
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Basic information
Public title
Phase II study of combination chemotherapy using paclitaxel, carboplatin, and bevacizumab in patients with advanced or recurrent cervical cancer.
Acronym
CC-Bev
Scientific Title
Phase II study of combination chemotherapy using paclitaxel, carboplatin, and bevacizumab in patients with advanced or recurrent cervical cancer.
Scientific Title:Acronym
CC-Bev
Region
| Japan |
Condition
Condition
cervical cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of combination chemotherapy using paclitaxel, carboplatin, and bevacizumab (TC+Bev therapy).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Objective response rate
Key secondary outcomes
Overall survival, Progression free survival, Toxicity
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Paclitaxel 175mg/m2
Carboplatin AUC =6
Bevacizumab 15mg/kg
Q 3 weeks
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
1. Histologically proven cervical cancer.
2. FIGO stage IVb or recurrent cervical cancer. Previous one or two regimens of chemotherapy is permitted.
3. Patient with assessable tumor.
4. ECOG PS: 0 to 2.
Key exclusion criteria
1. Previous paclitaxel or carboplatin administration within 6 months of registration.
2. Any active concomitant malignancy.
3. Severe comorbidity.
Target sample size
30
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
13-70Kitaoji-cho, Akashi-city
TEL
078-929-1151
nagao@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoji Nagao |
Organization
Hyogo Cancer Center
Division name
Gynecologic Oncology
Zip code
Address
13-70Kitaoji-cho, Akashi-city
TEL
078-929-1151
Homepage URL
nagao@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Cancer Center
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
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
| 2016 | Year | 09 | Month | 23 | 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
| 2016 | Year | 06 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 15 | 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
| 2016 | Year | 09 | Month | 23 | Day |
Last modified on
| 2016 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027794
