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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000008481
Receipt No. R000009225
Scientific Title Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery
Date of disclosure of the study information 2012/07/20
Last modified on 2020/03/24

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Basic information
Public title Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery
Acronym Randomized Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer
Scientific Title Randomized Phase III Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer after comprehensive staging surgery
Scientific Title:Acronym Randomized Trial of the need for adjuvant chemotherapy in stage I epithelial ovarian cancer
Region
Japan Asia(except Japan)

Condition
Condition Stage I epithelial ovarian cancer after comprehensive staging surgery
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the Overall survival of adjuvant chemotherapy versus observation in stage I epithelial ovarian cancer after comprehensive staging surgery
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Overall survival, OS
Key secondary outcomes Relapse-free survival/Adverse event for adjuvant chemotherapy/Rate of postoperative complications/Treatment or no-treatment for postoperative complications/Number of cycles for planned chemothrapy, histologic type, safety and efficacy for Generic anti-cancer drugs

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 considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 combination of paclitaxel and carboplatin
Interventions/Control_2 Observation
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 with a diagnosis of histopathologically epithelial ovarian cancer
2) FIGO Stages Ia(Grade2/3, clear cell carcinoma), Ib(Grade2/3, clear cell carcinoma) and Ic(b)(all degree of differentiation and all histologic type)
3) Patients with a diagnosis of advanced stage by comprehensive staging or restaging laparotomy.
4) Patients who received comprehensive staging surgery (basic surgical techniques (total hysterectomy, bilateral salpingo-oophorectomy, and omentectomy) as well as peritoneal cytology, multiple biopsies of the peritoneum ([Peritoneal biopsy] see details below), retroperitoneal lymph node dissection (see details below [Retroperitoneal lymph node dissection]).
However, for the following cases, it is eligible as a condition to record on the official document.
* Peritoneal biopsy: peritoneal metastasis is not recognized by macroscopic and palpation in the stipulated site, and the case that biopsy has not been performed.
* Retroperitoneal lymph node dissection: the case that lymph nodes of the stipulated range has been dissected however the prescribed number has not been reached.
5) Age: 20 or older
6) Performance status (PS):0-1
7) Case with initial therapy for postoperative primary lesion
8) Patient possible to receive the first study treatment within 8 weeks after the comprehensive staging surgery
9) Reasonable organ function
10) Patient must have signed informed consent.
Key exclusion criteria 1) FIGO Stages Ic(a), Ic(1) and Ic(2)
2) Patients containing sarcoma elements
3) Patients with any signs of interstitial pneumonia or pulmonary fibrosis by chest radiography
and CT
4) Patients with serious complications
5) Patients with active infection
6) Patients with intestinal paralysis or intestinal obstruction
7) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy
8) Patients with previous chemotherapy or radiation therapy
9) Patients with serious drug hypersensitivity
10) Patients with peripheral motor/sensory neuropathy (grade2,3,4 CTC-AE 4.0)
11) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
12) Patients with positive HBsAg.Patients with more than 2.1 log/copies ml based on fixed HBV-DNA who are positive with either antigen-positive HBs, anti-hepatitis B core antigen or anti-hepatitis B surface antigen.
13) Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Target sample size 460

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Tanabe
Organization The Jikei University School of Medicine
Division name Department of Obsterics and gynecology
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo, 105-8461 Japan
TEL 03-3433-1111
Email jgog3020@jgog.gr.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Tanabe
Organization JGOG3020 Coordinating Office
Division name The Jikei University School of Medicine ,gynecology
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku,Tokyo, 105-8461 Japan
TEL 03-3433-1111
Homepage URL http://www.jgog.gr.jp/
Email jgog3020@jgog.gr.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Japanese Gynecologic Oncology Group
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese Gynecologic Oncology Group
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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 東京慈恵会医科大学附属柏病院(千葉県)
市立貝塚病院(大阪府)
東海大学医学部付属病院(神奈川県)
弘前大学医学部附属病院(青森県)
静岡赤十字病院(静岡県)
東京慈恵会医科大学附属病院(東京都)
東京慈恵会医科大学附属葛飾医療センター(東京都)
綜合病院山口赤十字病院(山口県)
市立函館病院(北海道)
四国がんセンター独法(愛媛県)
自治医科大学附属病院(栃木県)
埼玉医科大学国際医療センター(埼玉県)
岩手医科大学附属病院(埼玉県)
県立広島病院(広島県)
兵庫県立がんセンター(兵庫県)
市立三次中央病院(広島県)
埼玉県立がんセンター(埼玉県)
大阪大学医学部附属病院(大阪府)
鳥取大学医学部附属病院(鳥取県)
横浜市立市民病院(神奈川県)
豊見城中央病院(沖縄県)
厚生連札幌厚生病院(北海道)
伊勢赤十字病院(三重県)
鳥取県立中央病院(鳥取県)
立正佼成会附属佼成病院(東京都)
東邦大学医療センター 大橋病院(東京都)
藤田医科大学病院(愛知県)
東京女子医科大学病院(東京都)
慶應義塾大学病院(東京都)
久留米大学病院(福岡県)
愛知県がんセンター(愛知県)
鹿児島市立病院(鹿児島県)
関西ろうさい病院独法(兵庫県)
岐阜大学医学部附属病院(岐阜県)
熊本大学病院(熊本県)
東北大学病院(宮城県)
防衛医科大学校病院(埼玉県)
琉球大学医学部附属病院(沖縄県)
神戸市立医療センター中央市民病院(兵庫県)
大阪市立大学医学部附属病院(大阪府)
東京慈恵会医科大学附属第三病院(東京都)
公立陶生病院(愛知県)
九州医療センター独法(福岡県)
札幌医科大学附属病院(北海道)
愛知医科大学病院(愛知県)
筑波大学附属病院(茨城県)
大阪国際がんセンター(大阪府)
がん・感染症センター都立駒込病院(東京都)
独立行政法人地域医療機能推進機構徳山中央病院(山口県)
大阪医科大学附属病院(大阪府)
沖縄県立中部病院(沖縄県)
山形大学医学部附属病院(山形県)
九州がんセンター独法(福岡県)
徳島大学病院(徳島県)
がん研究会有明病院(東京都)
東京医科歯科大学医学部附属病院(東京都)
九州大学病院(福岡県)
静岡県立静岡がんセンター(静岡県)
近畿大学病院(大阪府)
姫路赤十字病院(兵庫県)
国家公務員共済組合連合会立川病院(東京都)
厚生連JA広島総合病院(広島県)
愛媛大学医学部附属病院(愛媛県)
東京大学医学部附属病院(東京都)
鹿児島大学病院(鹿児島県)
広島市立広島市民病院(広島県)
東京都立多摩総合医療センター(東京都)
新潟県立がんセンター新潟病院(新潟県)
獨協医科大学埼玉医療センター(埼玉県)
新潟大学医歯学総合病院(新潟県)
京都第一赤十字病院(京都府)
信州大学医学部附属病院(長野県)
越谷市立病院(埼玉県)
聖マリアンナ医科大学病院(神奈川県)
長崎大学病院(長崎県)
北海道大学病院(北海道)
獨協医科大学病院(栃木県)
松阪中央総合病院(三重県)
三重大学病院(三重県)
済生会長崎病院(長崎県)
横浜市立大学附属病院(神奈川県)
埼玉病院(埼玉県)
東京女子医科大学東医療センター(東京都)
横浜南共済病院(神奈川県)
佐賀大学医学部附属病院(佐賀県)
長野市民病院(長野県)
北里大学病院(神奈川県)
佐々木研究所附属杏雲堂病院(東京都)
日本医科大学付属病院(東京都)
島根大学医学部附属病院(島根県)
堺市立総合医療センター(大阪府)
群馬県立がんセンター(群馬県)
群馬大学医学部附属病院(群馬県)
神奈川県立がんセンター(神奈川県)
Seoul ST' Mary's Hospital(Korea)
National Cancer Center(Korea)
大分大学医学部附属病院(大分県)
Kangbuk Samsung Hospital(Korea)
Severance Hospital(Korea)
Gachon University Gil Medical Center(Korea)
国立がん研究センター東病院(千葉県)
日本大学医学部附属板橋病院(東京都)
神戸大学医学部附属病院(兵庫県)
大和市立病院(神奈川県)
Gangnam Severance Hospital(Korea)
Obstetrics and Gynecology Hospital(Shanghai)
Zhongshan Hospital(Shanghai)

Other administrative information
Date of disclosure of the study information
2012 Year 07 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
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 Open public recruiting
Date of protocol fixation
2012 Year 04 Month 27 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 20 Day
Last follow-up date
2029 Year 07 Month 01 Day
Date of closure to data entry
2029 Year 07 Month 01 Day
Date trial data considered complete
2029 Year 10 Month 01 Day
Date analysis concluded
2030 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 07 Month 20 Day
Last modified on
2020 Year 03 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009225

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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