UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017247 |
|---|---|
| Receipt number | R000020011 |
| Scientific Title | An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial- |
| Date of disclosure of the study information | 2015/04/22 |
| Last modified on | 2021/12/13 14:35:58 |
* 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
An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial-
Acronym
JGOG3023
Scientific Title
An open-label, randomized, phase II trial evaluating the efficacy and safety of standard of care with or without Bevacizumab in Platinum-resistant ovarian cancer patients previously treated with Bevacizumab for front-line or Platinum-sensitive ovarian cancer: -JGOG3023 trial-
Scientific Title:Acronym
JGOG3023
Region
| Japan |
Condition
Condition
platinum-resistant recurrent ovarian cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical benefit of continued Bevacizumab treatment (Bevacizumab beyond progression disease) in combination with single agent chemotherapy for patients with platinum-resistant, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have progressed after treatment with front line or platinum-sensitive chemotherapy combined with Bevacizumab, 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 survival: OS
Objective Response Rate: ORR
Safety
Number of paracentesis
Tumor marker (CA125) response rate"
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy + Bevacizumab
Interventions/Control_2
chemotherapy alone
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.Patients histologocally confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
2.Patients must have platinum-resistant disease (defined as progression within <6 months from completion of a minimum of 3 platinum therapy (including Bevacizumab) cycles. (Assessment for disease progression by tumor marker alone is not accepted.)
3.Patients >= 20 years of age.
4.ECOG Performance Status: 0-2
5.Patients can be included if they have a RECIST progression, with either measurable or non-measurable disease. Patient who can be evaluated based on GCIG CA125 criteria is allowed
6.Life expectancy of >= 90 days.
7.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.
8.Adequate following organ function.
a.Neutrophils count >= 1,500 /mm3
b.Platelet count >= 10.0x104 /mm3
c.Hemoglobin >= 9.0 g/dL (Transfusion to maintain >= 9.0 g/dl acceptable)
d.Total bilirubin =< 1.2 mg/dL
e.AST, ALT =< 100 IU/L (For patients with liver meatstasis, =< 200 IU/L)
f.Serum creatine =< 1.5 mg/dL
g.Proteinuria =< 1+ (>= 2 +:Confirm that =< 1.0 g in 24 hour urine collection or =< 1.0 the protein / creatinine ratio (UPC ratio) of occasional urine.)
h.PT-INR max. =< 1.5 (However, while taking warfarin 1.5 =< PT-INR =< 2.5)
Key exclusion criteria
1.Patient with ovarian borderline malignant tumor.2.History of other clinically active malignancy within 5 years of enrollment,3.Previous treatment with >= 4 anticancer regimens.4.History of bowel obstruction, including sub-occlusive disease, related to the underlying disease and history of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess. Evidence of recto-sigmoid involvement by pelvic examination or bowel involvement on CT scan or clinical symptoms of bowel obstruction.5.Surgery within 28 days prior to the start of study, or anticipation of the need for major surgery during study treatment.6.Current or recent (within 10 days prior to the first study drug dose) chronic daily treatment with aspirin (>325 mg/day) or clopidogreln (of more than 75 mg/day).prophylactic use of anticoagulations is allowed.7.Palliative radiotherapy < 14 days prior to anticipate in this study.8.LVEF defined by MUGA/ECHO below 50% (only applicable for patients intended to be treated with pegylated liposomal doxorubicin).9.Pre-existing peripheral neuropathy >=CTC grade 2 for those patients planned to receive paclitaxel.10.Symptomatic CNS metastasis.11.Pregnant or lactating females. or Women of childbearing potential not using highly-effective contraception.12.Patient having the following conditions: a.History or evidence of thrombotic or hemorrhagic disorders. b.New York Heart Association (NYHA) grade II or greater congestive heart failure(CHF) c.serious cardiac arrhythmia requiring medication d.Uncontrolled hypertension e.Non-healing wound, ulcer or bone fracture. f.HBsAg(+), HBcAb and/or HBsAb(+)and >=2.1 log copies/ml of HBV-DNA levels, or HIV(+).13.Current or recent treatment with another investigational drug within 30 days of first study treatment dosing or earlier participation in this study.14.Known hypersensitivity to any of the study drugs or excipients.15.Patient who is judged inappropriate to participate in this study by the principle investigator.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Tadahiro |
| Middle name | |
| Last name | Shoji |
Organization
Iwate Medical University Hospital
Division name
Obstetrics and Gynecology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-g un, Iwate Pref
TEL
019-613-7111
tshoji@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Tadahiro |
| Middle name | |
| Last name | Shoji |
Organization
Iwate Medical University Hospital
Division name
Obstetrics and Gynecology
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-g un, Iwate Pref
TEL
019-613-7111
Homepage URL
http://www.jgog.gr.jp/
tshoji@iwate-med.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO.,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
National Cancer Center Hospital East Certified Review Board
Address
6-5-1 Kashiwanoha, Kashiwa-shiChiba-ken, 277-8577 Japan
Tel
04-7133-1111
ncche-irb@east.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs031180244
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岩手医科大学附属病院（岩手県）、
愛媛大学医学部附属病院（愛媛県）、
東邦大学医療センター大橋病院（東京都）、
NTT東日本関東病院（東京都）、
東北大学病院（宮城県）、
長崎大学病院（長崎県）、
鳥取大学医学部附属病院（鳥取県）、
横浜市立大学附属病院（神奈川県）、
関西労災病院（兵庫県）、
山形大学医学部附属病院（山形県）、
四国がんセンター（愛媛県）、
藤田医科大学病院（愛知県）、
福井大学医学部附属病院（福井県）、
東京慈恵医科大学附属柏病院（千葉県）、
慶應義塾大学病院（東京都）、
静岡県立静岡がんセンター（静岡県）、
新潟大学医歯学総合病院（新潟県）、
新潟県立がんセンター新潟病院（新潟県）、
北海道大学病院（北海道）、
がん研究会有明病院（東京都）、
大阪国際がんセンター（大阪府）、
東京大学医学部附属病院（東京都）、
聖マリアンナ医科大学病院（神奈川県）、
大阪医科大学附属病院（大阪府）、
久留米大学病院（福岡県）、
徳山中央病院（山口県）、
岐阜大学医学部附属病院（岐阜県）、
横浜南共済病院（神奈川県）、
JA北海道厚生連旭川厚生病院（北海道）、
名古屋大学医学部附属病院（愛知県）、
九州大学病院（福岡県）、
静岡赤十字病院（静岡県）、
字社八戸赤十字病院（青森県）、
近畿大学医学部附属病院（大阪府）、
愛知県がんセンター中央病院（愛知県）、
福島県立医科大学附属病院（福島県）、
茨城県立中央病院（茨城県）、
杏林大学医学部付属病院（東京都）、
川崎医科大学総合医療センター（岡山県）、
東京慈恵会医科大学附属病院（東京都）、
弘前大学医学部附属病院（青森県）、
順天堂大学医学部附属練馬病院（東京都）、
東北医科薬科大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 22 | Day |
Related information
URL releasing protocol
http://www.jgog.gr.jp/kaiin/kaiin2/enforcement_outline/jgog3023/jgog3023.html
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/34716979/
Number of participants that the trial has enrolled
103
Results
We investigated the efficacy and safety of further bevacizumab therapy in platinum-resistant ovarian cancer patients whose disease had progressed after bevacizumab plus chemotherapy. Bevacizumab was effective beyond progressive disease and AEs were manageable.
(The 58th Annual Meeting of Japan Society of Clinical Oncology)
Results date posted
| 2021 | Year | 12 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 10 | Month | 30 | Day |
Baseline Characteristics
The mean +/- SD age of patients was 60.7 +/- 12.15 years in the chemotherapy group and 60.3 +/- 9.71 years in the chemotherapy + bevacizumab group. Serous carcinoma was the most common histological category in both groups. Twelve patients in each group had a platinum-free interval of zero during the study treatment and use of bevacizumab as a front-line therapy was similar in both groups. Baseline characteristics were well balanced between groups.
Participant flow
A total of 103 patients were enrolled and allocated to the chemotherapy group (n=51) and chemotherapy + bevacizumab group (n=52); all of these patients were included in the ITT analysis set.
Adverse events
The overall incidence of AEs was 100% in the chemotherapy group and 98.0% in the chemotherapy + bevacizumab group, and that of treatment-related AEs was 96.0% in the chemotherapy group and 96.1% in the chemotherapy + bevacizumab group. The AEs were generally manageable; only two patients in the chemotherapy group and 12 patients in the chemotherapy + bevacizumab group discontinued treatment due to AE.
Outcome measures
The median investigator-assessed PFS (primary endpoint) was 3.1 months (95% CI: 2.5-4.6) in the chemotherapy group and 4.0 months (95% CI: 3.0-5.7) in the chemotherapy + bevacizumab group (HR=0.54, 95% CI: 0.32-0.90, one-sided P=0.0082)
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 07 | Month | 07 | Day |
Date of closure to data entry
| 2019 | Year | 07 | Month | 30 | Day |
Date trial data considered complete
| 2019 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 22 | Day |
Last modified on
| 2021 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020011
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
