UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041175 |
|---|---|
| Receipt number | R000047015 |
| Scientific Title | A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database |
| Date of disclosure of the study information | 2020/07/27 |
| Last modified on | 2022/12/05 17:01:46 |
* 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
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
Acronym
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
Scientific Title
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
Scientific Title:Acronym
A cohort study on the safety of bevacizumab in combination with neoadjuvant chemotherapy in the initial treatment of advanced ovarian cancer using a Japanese healthcare database
Region
| Japan |
Condition
Condition
Advanced ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the safety information of bevacizumab in combination with neoadjuvant chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of gastrointestinal perforation of neoadjuvant chemotherapy in combination with or without bevacizumab in the initial treatment of advanced ovarian cancer, and the risk ratio and risk difference of bevacizumab in combination with neoadjuvant chemotherapy compared to chemotherapy alone
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with ovarian cancer, fallopian tube cancer or peritoneal cancer from April 1, 2008 to January 29, 2020
Key exclusion criteria
Patients with cancer other than ovarian cancer, fallopian tube cancer or peritoneal cancer
Target sample size
48000
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ouchi |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Affairs Div.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo 103-8324, Japan
TEL
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Co., Ltd. |
| Middle name | |
| Last name | Chugai Pharmaceutical |
Organization
Medical Affairs Div.
Division name
Medical Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-ku, Tokyo 103-8324, Japan
TEL
03-3273-0866
Homepage URL
cma-clinicaltrial@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS
Address
15-14 Dogenzaka 1-Chome, Shibuya-ku, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
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
| 2020 | Year | 07 | Month | 27 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Unpublished
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36245228/
Number of participants that the trial has enrolled
7839
Results
PTX+CBDCA (TC) was most commonly used as first-line treatment. TC+Bev was used in 9.3% and 11.6% of patients in the NAC and PDS groups, respectively. The proportion of patients with risk factors for GI perforation in the TC+Bev group of NAC was lower compared to patients without Bev. The incidence of GI perforation in the NAC group was 0.38% in patients receiving TC+Bev and 0.18% in patients receiving TC without Bev (risk ratio=2.13; 95%CI=0.19 to 23.36; risk difference=0.20; 95%CI=-0.58 to 0.97).
Results date posted
| 2022 | Year | 12 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
Patients diagnosed with ovarian, fallopian tube or peritoneal cancer and first treated between 1 April 2008 and 29 January 2020
(Patients with suspected recurrence and patients diagnosed with other cancers are excluded)
Participant flow
Patients were divided into two groups: the NAC group (IDS after NAC) and the PDS group (adjuvant chemotherapy after PDS). 2864 patients in the NAC group and 2760 patients in the PDS group were selected from each group from 22 November 2013 to 30 January 2019, considering the approval date of Bev and the observation period. Cases treated with the CBDCA+PTX (TC) combination therapy and TC+Bev combination therapy were selected for adverse event analysis.
Adverse events
None
Outcome measures
Incidence rates, risk ratios and risk differences for gastrointestinal perforation during the first treatment period in advanced ovarian cancer first-line NAC with and without Bev combination therapy
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2008 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cohort study using a Japanese healthcare database
Management information
Registered date
| 2020 | Year | 07 | Month | 21 | Day |
Last modified on
| 2022 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047015
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
