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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005487
Receipt No. R000006500
Scientific Title Intergroup trial: Randomized Phase II Clinical Trial of Pegylated Liposomal Doxorubicin plus Carboplatin versus Gemcitabine plus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma after Failure of Initial Platinum-based Chemotherapy
Date of disclosure of the study information 2011/04/22
Last modified on 2018/08/20

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Basic information
Public title Intergroup trial: Randomized Phase II Clinical Trial of Pegylated Liposomal Doxorubicin plus Carboplatin versus Gemcitabine plus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma after Failure of Initial Platinum-based Chemotherapy
Acronym iPLAS trial/GOTIC-003
Scientific Title Intergroup trial: Randomized Phase II Clinical Trial of Pegylated Liposomal Doxorubicin plus Carboplatin versus Gemcitabine plus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma after Failure of Initial Platinum-based Chemotherapy
Scientific Title:Acronym iPLAS trial/GOTIC-003
Region
Japan

Condition
Condition Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of Pegylated Liposomal Doxorubicin plus Carboplatin versus Gemcitabine plus Carboplatin in Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, Peritoneal Carcinoma after Failure of Initial Platinum-based Chemotherapy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Progression-free survival
Key secondary outcomes Overall response rate
Overall survival
Adverse event
Tolerability

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
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)(30mg/m2) day1 + Carboplatin(AUC5) day1 q28days 6cycles
Interventions/Control_2 Gemcitabine(GEM)(1000mg/m2) day1and 8 + Carboplatin(AUC4) day1 q21days 6cycles
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)Histologically proven epithelial ovarian carcinoma, primally carcinoma of fallopian tube, or peritoneal carcinoma
2)Patients with platinum-sensitive recurrent ovarian cancer at least 6 months after completion of first-line, platinum-based therapy
3)Patients have at least one measurable or nonmeasurable disease.
4)Patients at least 20-years-old
5)Patients at an ECOG Performance Status of 0 to 2
6)Patients with adequate organ function
7)Patients with estimated life expevtancy of 4 months or longer
8)Patients obtained written informed consent
Key exclusion criteria 1)Patients with fever of over 38.0 degrees C
2)Patients with active infection
3)Patients with serious complications
4)Patients with a second primary malignancy (except in situ carcinoma of the cervix
or adequately treated basal cell carcinoma of the skin)
5)Patients with prior radiation therapy
6)Patients with pleural effusion,ascites or pericardial effusion which requires persistent drainage
7)Patients with prior treatment of Anthracycline or Gemcitabine Hydrochloride
8)Patients with clinical symptom of brain metastasis requiring medication
9)Patients with hepatic damage (hepatitis,hepatic cirrhosis), history or evidence upon alcoholism
10)Patients with positive HBsAg.
11)Patients with a history of hypersensitivity to Doxorubicin
12)Patients who are pregnant or nursing or of child bearing potential
13)Patients judged inappropriate for this study by the physicians
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Fujiwara,M.D.,Ph.D.
Organization Jichi Medical University
Division name Department of Obstetrics and Gynecology
Zip code
Address 3311-1 Yakushiji ,Shimotsuke-city Tochigi, 329-0498 Japan
TEL 0285-58-7376
Email fujiwara@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuji Takei,M.D.,Ph.D/Izumi Kohara,RN,Ph.D,CCRP.
Organization iPLAS Trial Office
Division name Jichi Medical University, Department of Obstetrics and Gynecology
Zip code
Address 3311-1 Yakushiji ,Shimotsuke-city Tochigi, 329-0498 Japan
TEL 0285-58-7376
Homepage URL
Email fujiwara@jichi.ac.jp

Sponsor
Institute Gynecologic Oncology Trial and Investigation Consortium
Institute
Department

Funding Source
Organization Gynecologic Oncology Trial and Investigation Consortium
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 兵庫医科大学病院(兵庫県)
鳥取大学医学部付属病院(鳥取県)
自治医科大学付属病院(栃木県)
久留米大学病院(福岡県)
埼玉医科大学国際医療センター(埼玉県)
埼玉社会保険病院(埼玉県)
東北大学病院(宮城県)
関西労災病院(兵庫県)
独立行政法人国立病院機構四国がんセンター(愛媛県)
立正佼成会附属佼成病院(東京都)
防衛医科大学校病院(埼玉県)
岩手医科大学附属病院(岩手県)
市立三次中央病院(広島県)
独立行政法人国立病院機構呉医療センター・中国がんセンター(広島県)
独立行政法人国立病院機構九州がんセンター(福岡県)
総合病院山口赤十字病院(山口県)
弘前大学病院(青森県)
鳥取市立病院(鳥取県)
独立行政法人国立病院機小倉医療センター(福岡県)
奈良県立医科大学附属病院(奈良県)
大阪大学医学部附属病院(大阪府)
静岡県立静岡がんセンター(静岡県)
埼玉県立がんセンター(埼玉県)
長岡赤十字病院(新潟県)
長岡中央綜合病院(新潟県)
JA新潟厚生連 上越総合病院(新潟県)
新潟市民病院(新潟県)
新潟県立がんセンター新潟病院(新潟県)
新潟大学医歯学総合病院(新潟県)
香川県立中央病院(香川県)
兵庫県立がんセンター(兵庫県)
山形大学医学部附属病院(山形県)
三重大学医学部附属病院(三重県)
愛知県がんセンター中央病院(愛知県)
九州大学病院(福岡県)
新潟県立新発田病院(新潟県)
東京慈恵会医科大学附属柏病院(千葉県)
東京慈恵会医科大学附属病院(東京都)
愛媛大学医学部附属病院(愛媛県)

Other administrative information
Date of disclosure of the study information
2011 Year 04 Month 22 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 Completed
Date of protocol fixation
2011 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 23 Day
Last follow-up date
2016 Year 11 Month 06 Day
Date of closure to data entry
2017 Year 02 Month 06 Day
Date trial data considered complete
2017 Year 05 Month 06 Day
Date analysis concluded
2017 Year 08 Month 06 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 22 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006500

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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