UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000017247
Receipt No. 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 (Ver. 31)

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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
Obsterics 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
Email 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/
Email tshoji@iwate-med.ac.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020011