UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013164 |
|---|---|
| Receipt number | 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 14:25:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
| Obstetrics 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
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/
komiyama@med.toho-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
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
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
Value
https://center6.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 |
