UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026063 |
|---|---|
| Receipt number | R000029934 |
| Scientific Title | A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer. |
| Date of disclosure of the study information | 2017/02/10 |
| Last modified on | 2019/02/11 14:10:56 |
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Basic information
Public title
A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer.
Acronym
JGOG1079
Scientific Title
A phase II study for the efficacy of bevacizumab with paclitaxel and carboplatin in patient with stage IVB, recurrent or persistant cervical cancer.
Scientific Title:Acronym
JGOG1079
Region
| Japan |
Condition
Condition
Stage IVB, recurrent or persistant cervical cancer
Classification by specialty
| Endocrinology and Metabolism | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical benefit of Bevacizumab treatment in combination with chemotherapy of Paclitaxel plus Carboplatin for patients with Stage IVB, recurrent or persistant cervical cancer as measured by the investigator assessed progression free survival(PFS).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Progression Free Survival: PFS
Key secondary outcomes
Overall Response Rate: ORR
Overall Survival: OS
Time to Treatment Failure: TTF
Safety
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 day1
Carboplatin AUC=5 day1
Bevacizumab 15mg/kg day1
tri-weekly
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.Signed informed consent obtained prior to initiation of any study-specific procedures and treatment as confirmation of the patient's awareness and willingness to comply with the study requirements.
2.More than 20 years old
3.ECOG Performance Status: 0-2
4.Life expectancy of >= 90 days
5.Histologically confirmed cervical cancer by histopathologic examination of uterine cervix
6.Patients with a diagnosis of confirmed cervical cancer such as squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
7.Patients can be included if they have measurable diseases.
8.Adequate following organ function.
Key exclusion criteria
1.Patient who has received any cheotherapy except for CCRT
2.Patient with perforation of the digestive tract and severe fistula within 6 months before registration
3.Patient with a history of hypersensitivity to the drug used in combination to bevacizumab
4.Patient with active infection at registration
5. Patient with uncontrolled hypertension at registration
6.Patient suspected or diagnosed as arterial thromboembolism (cerebral infarction, myocardial infarction, etc.) at registration
7.Patient who is judged inappropriate to participate in this study by the attending physician
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhiro Takeshima, M.D. |
Organization
Cancer Institute Hospital
Division name
Department of Gynecology
Zip code
Address
3-8-31, Ariake, Koutou-ku,Tokyo, 135-8550 Japan
TEL
03-3520-0111
nobuhiro.takeshima@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Maki Matoda, M.D. |
Organization
Cancer Institute Hospital
Division name
Department of Gynecology
Zip code
Address
3-8-31, Ariake, Koutou-ku,Tokyo, 135-8550 Japan
TEL
03-3520-0111
Homepage URL
maki.matsumura@jfcr.or.jp
Sponsor or person
Institute
Japan Gynecologic Oncology Group:JGOG
Institute
Department
Personal name
Funding Source
Organization
Japan Gynecologic Oncology Group:JGOG
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
| 2017 | Year | 02 | Month | 10 | 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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 02 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 02 | Month | 09 | Day |
Last modified on
| 2019 | Year | 02 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029934
