UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficasy and safety of bevacizumab in combination with chemotherapy for treating the first recurrence of ovarian carcinoma : Phase 2 study
Title of the study (Brief title)	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	Obsterics 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	Tatsuya Matsunaga
Organization	Yokohama city univesity
Division name	Obstetrics and Gynecology
Address	Fukuura 3-9, Kanazawa-ku, Yokohama-city
TEL	045-787-2800
Email	tyamatsu@yokohama-cu.ac.jp

Public contact
Name of contact person	Tatsuya Matsunaga
Organization	Yokohama city univesity
Division name	Obstetrics and Gynecology
Address	Fukuura 3-9, Kanazawa-ku, Yokohama-city
TEL	045-787-2800
Homepage URL
Email	tyamatsu@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama city univesity Obstetrics and Gynecology
Institute
Department

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)

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

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2015 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017750