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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003130
Receipt No. R000003793
Scientific Title Randomized Phase III Trail of Liposomal Doxorubicin(PLD)50mg/m2 versus Liposomal Doxorubicin(PLD)40mg/m2 in Patients with Platinum-Refractory and -Resistant Mullerian Carcinoma (Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma).
Date of disclosure of the study information 2010/02/02
Last modified on 2018/08/16

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Basic information
Public title Randomized Phase III Trail of Liposomal Doxorubicin(PLD)50mg/m2 versus Liposomal Doxorubicin(PLD)40mg/m2 in Patients with Platinum-Refractory and -Resistant Mullerian Carcinoma (Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma).
Acronym Randomized Trial of PLD 50mg/m2 vs PLD 40mg/m2 for Platinum-Refractory and -Resistant Mullerian Carcinoma
Scientific Title Randomized Phase III Trail of Liposomal Doxorubicin(PLD)50mg/m2 versus Liposomal Doxorubicin(PLD)40mg/m2 in Patients with Platinum-Refractory and -Resistant Mullerian Carcinoma (Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma).
Scientific Title:Acronym Randomized Trial of PLD 50mg/m2 vs PLD 40mg/m2 for Platinum-Refractory and -Resistant Mullerian Carcinoma
Region
Japan

Condition
Condition Patients with platinum-refractory and -resistant Mullerian Carcinoma (epithelial ovarian, fallopian tube, primary peritoneal carcinoma)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare progression-free survival in patients with platinum-refractory and-resistant Mullerian carcinoma receiving PLD 50mg/m2 and PLD 40mg/m2.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase III

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Adverse event
Response Rate
Overall Suvival
Tolerability

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 Liposomal Doxorubicin(PLD)50mg/m2
Interventions/Control_2 Liposomal Doxorubicin(PLD)40mg/m2
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
79 years-old >=
Gender Female
Key inclusion criteria 1)Mullerian Carcinoma(epithelial ovarian, fallopian tube, or primary peritoneal carcinoma)
2)Prior platinum-based chemotherapy is required. Platinum-resistant disease is based on the most recent exposure to a platinum-based regimen and is defined as progressive disease within 6 months of completing the prior therapy. Criteria eligibility also included the presence of measurable disease.
3)No more than two prior regimens are allowed.
4)No chemotherapy within 4 weeks prior to the registration
5)Age:20 years old -79 years old
6)Performance status:ECOG 0-2
7)Adequate bone marrow, renal, and hepatic function
8)Patients are expected to live more than 3 months.
9)Patients who have signed an approved informed consent.
Key exclusion criteria 1) Patients who have a history of hypersensitivity to Doxorubicin
2) Patients with active infection
3) Patients with severe complications (Heart disease, uncontrolled diabetes, malignant hypertension, or bleeding tendency)
4) Patients who have any other cancer within the past 5 years
5) Patients have myocardial infarction within 90 days or angina attack.
6) Patients who have treated prior chemotherapy with Anthracycline of a total dose of more than 250 mg/m2 doxorubicin
7) Patients have received prior PLD chemotherapy.
8) Patients have symptomatic brain metastasis with symptom.
9) Patients are pregnant or breast feeding.
10)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician.
Target sample size 470

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsutomu Tabata , M.D., Ph.D.
Organization Mie University Hospital
Division name Department of Obsterics and Gynecology
Zip code
Address 2-174 Edobashi, Tsu-city, Mie, 514-8507 Japan
TEL 059-232-1111
Email jgog3018@jgog.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsutomu Tabata ,M.D.,
Organization JGOG3018 Coordinating Office
Division name Mie University Hospital Department of Obsterics and Gynecology
Zip code
Address 2-174 Edobashi, Tsu-shi, Mie, 514-8507 Japan
TEL 059-232-1111
Homepage URL http://www.jgog.gr.jp/
Email jgog3018@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
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 三重大(三重)山田赤十字病院(三重)三沢病院(青森)済生会吹田病院(大阪)山口赤十字病院(山口)埼玉社保病院(埼玉)立正佼成会病院(東京)長崎市民病院(長崎)近江八幡総合医療センター(滋賀)岩手医大(岩手)広島大(広島)静岡赤十字病院(静岡)鳥取大(鳥取)KKR札幌医療センター(北海道)がん・感染症センター駒込病院(東京)仙台医療センター(宮城)社保田川病院(福岡)久留米大(福岡)札幌厚生病院(北海道)東北大(宮城)慶應大(東京)山口大(山口)大分大(大分)与謝の海病院(京都)千葉医療センター(千葉)京都市立病院(京都)鹿児島市立病院(鹿児島)横浜市民病院(神奈川)癌研有明病院(東京)名古屋市立大(愛知)四国がんセンター(愛媛)三井記念病院(東京)中部病院(沖縄)中国労災病院(広島)関西労災病院(兵庫)弘前大(青森)済生会日田病院(大分)奈良県立医大(奈良)北里大(神奈川)長崎大(長崎)埼玉県立がんセンター(埼玉)埼玉病院(埼玉)JA広島病院(広島)豊見城中央病院(沖縄)聖隷浜松病院(静岡)鹿児島大(鹿児島)横浜市立大(神奈川)新潟県立がんセンター(新潟)東京大(東京)東京医療センター(東京)聖マリアンナ医大(神奈川)防衛医大(埼玉)塚口病院(兵庫)三重総合医療センター(三重)愛知県がんセンター(愛知)岐阜大(岐阜)東邦大大橋病院(東京)聖マリア病院(福岡)名古屋大(愛知)小倉記念病院(福岡)島根中央病院(島根)近畿大(大阪)東海大(神奈川)金沢医大(石川)三次中央病院(広島)函館五稜郭病院(北海道)独協医大(栃木)埼玉医大国際医療センター(埼玉)大阪医大(大阪)旭川医大(北海道)京都第一赤十字病院(京都)浜松医大(静岡)群馬県立がんセンター(群馬)九州医療センター(福岡)藤田保健衛生大(愛知)鳥取市立病院(鳥取)佐賀大(佐賀)新潟大(新潟)福山医療センター(広島)名古屋第二赤十字病院(愛知)順天堂大(東京)順天堂練馬病院(東京)JR札幌病院(北海道)埼玉医大総合医療センター(埼玉)筑波大(茨城)近大堺病院(大阪)信州大(長野)東京女子医大(東京)慈恵医大(東京)神戸大(兵庫)九州大(福岡)自治医大(栃木)大阪市大(大阪)産業医大(北九州)姫路赤十字病院(兵庫)慈恵柏病院(千葉)慈恵第三病院(千葉)慈恵青戸病院(東京)東京医科歯科大(東京)済生会長崎病院(長崎)松阪中央総合病院(三重)公立陶生病院(愛知)大阪市立総合医療センター(大阪)尾道総合病院(広島)香川県立中央病院(香川)県立広島病院(広島)旭川厚生病院(北海道)熊本大学(熊本)川崎市立井田病院(神奈川)愛媛大学(愛媛)北海道大学(北海道)越谷市立(埼玉)京都市立(京都)豊橋市民(愛知)茨城医療センター(茨城)山形大学(山形)福岡総合(福岡)八戸赤十字(青森)鹿児島医療センター(鹿児島)帝京千葉(千葉)多摩総合(東京)横須賀共済(神奈川)長崎医療センター(長崎)  昭和大学 藤が丘病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 02 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 Terminated
Date of protocol fixation
2009 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 01 Day
Last follow-up date
2018 Year 08 Month 01 Day
Date of closure to data entry
2018 Year 09 Month 01 Day
Date trial data considered complete
2018 Year 12 Month 01 Day
Date analysis concluded
2019 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 02 Month 02 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003793

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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