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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026063
Receipt No. 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

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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 Obsterics 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
Email 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
Email maki.matsumura@jfcr.or.jp

Sponsor
Institute Japan Gynecologic Oncology Group:JGOG
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029934

Research Plan
Registered date File name
2018/02/10 JGOG1079_Protcol_Ver.1.1.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name


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