UMIN-CTR Clinical Trial

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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