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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013164
Receipt No. R000015349
Scientific Title Prospective cohort study of bevacizumab plus standard platinum based chemotherapy as front-line treatment for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer:Japanese Gynecologic Oncology Group study
Date of disclosure of the study information 2014/02/14
Last modified on 2018/08/13

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Basic information
Public title Prospective cohort study of bevacizumab plus standard platinum based chemotherapy as front-line treatment for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer:Japanese Gynecologic Oncology Group study
Acronym Prospective cohort study of bevacizumab plus platinum based chemotherapy as front-line treatment for advanced epithelial ovarian cancer(JGOG3022)
Scientific Title Prospective cohort study of bevacizumab plus standard platinum based chemotherapy as front-line treatment for advanced epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer:Japanese Gynecologic Oncology Group study
Scientific Title:Acronym Prospective cohort study of bevacizumab plus platinum based chemotherapy as front-line treatment for advanced epithelial ovarian cancer(JGOG3022)
Region
Japan

Condition
Condition Epithelial Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of the addition of bevacizumab to platinum based chemotherapy as front-line treatment of FIGO stage III and IV epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Expression rate of the following adverse events in patients with tri-weekly paclitaxel and carboplatin plus bevacizumab
*Bevacizumab-specific adverse events
*Other Adverse events of Grade 3 or more
Key secondary outcomes Progression-free survival and response rate in patients with tri-weekly paclitaxel and carboplatin plus bevacizumab

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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.
1) Patient diagnosed with a stageIII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer in a primary surgery and expected to receive the first-line chemoterapy
2) Patient histologocally diagnosed with stageIII-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer and expected to receive the first post-operative chemoterapy after interval debulking surgery after neoadjuvant chemotherapy
2. Patient expected to receive combination therapy with bevacizumab and platinum based chemotherapy (iv) and consented to receive the treatment
3. Age: 20 or older at registration
4. No primary surgery or interval debulking surgery within 28 days prior to the study treatment
5. ECOG Performance Status: 0-2
6. Adequate bone marrow and organ function
7. No limitation is required with presence or absence of measurable lesions.
8.Patient expected to survive longer than 3 months
9.Patient can comply with the protocol.
10. Patient must have signed informed consent.
Key exclusion criteria 1.Patient who has received bevacizumab infusion
2.Patient with perforation of the digestive tract and severe fistula at registration
3.Patient with a history of hypersensitivity to the drug used in combination to bevacizumab
4.Patient with a history of hemoptysis (hemoptysis of fresh blood of 2.5ml or more)
5.Patient with a history of abdominal radiation therapy
6. Patient with active infection at registration
7. Pregnancy or during breast feeding or a patient willing to be pregnant
8. Patient with uncontrolled hypertension at registration
9.Patient suspected or diagnosed as arterial thromboembolism (cerebral infarction, myocardial infarction, etc.) at registration
10.Patient suspected or diagnosed as venous thromboembolism (deep vein thrombosis, pulmonary embolism, etc.) at registration
11.Patient of 2 + or more proteinuria at registration
12.Patient who is judged inappropriate to participate in this study by the attending physician
Target sample size 400

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Komiyama ,M.D.,Ph.D.
Organization Toho University Ohashi Medical Center
Division name Department of Obsterics and Gynecology
Zip code
Address 2-17-6, Ohashi ,Meguro-ku, Tokyo 153-8515 Japan
TEL 03-3468-1251
Email komiyama@med.toho-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Komiyama ,M.D.,Ph.D.
Organization Toho University Ohashi Medical Center
Division name Department of Obsterics and Gynecology
Zip code
Address 2-17-6, Ohashi ,Meguro-ku, Tokyo 153-8515 Japan
TEL 03-3468-1251
Homepage URL http://www.jgog.gr.jp/
Email komiyama@med.toho-u.ac.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Company Limited. And F. Hoffmann-La Roche, Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2014 Year 02 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs10147-018-1319-y
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 Completed
Date of protocol fixation
2014 Year 01 Month 27 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 Day
Last follow-up date
2017 Year 02 Month 23 Day
Date of closure to data entry
2017 Year 05 Month 01 Day
Date trial data considered complete
2017 Year 09 Month 22 Day
Date analysis concluded
2017 Year 11 Month 01 Day

Other
Other related information prospective observational study

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015349

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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