Unique ID issued by UMIN | UMIN000005487 |
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Receipt number | 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 11:09:38 |
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
iPLAS trial/GOTIC-003
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
iPLAS trial/GOTIC-003
Japan |
Platinum-Sensitive Patients with Recurrent Epithelial Ovarian Carcinoma, Primary Carcinoma of FallopianTube, and Peritoneal Carcinoma
Obstetrics and Gynecology |
Malignancy
NO
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
Safety,Efficacy
Phase II
Progression-free survival
Overall response rate
Overall survival
Adverse event
Tolerability
Interventional
Parallel
Randomized
Open -no one is blinded
Active
YES
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Liposomal Doxorubicin(PLD)(30mg/m2) day1 + Carboplatin(AUC5) day1 q28days 6cycles
Gemcitabine(GEM)(1000mg/m2) day1and 8 + Carboplatin(AUC4) day1 q21days 6cycles
20 | years-old | <= |
Not applicable |
Female
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
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
100
1st name | |
Middle name | |
Last name | Hiroyuki Fujiwara,M.D.,Ph.D. |
Jichi Medical University
Department of Obstetrics and Gynecology
3311-1 Yakushiji ,Shimotsuke-city Tochigi, 329-0498 Japan
0285-58-7376
fujiwara@jichi.ac.jp
1st name | |
Middle name | |
Last name | Yuji Takei,M.D.,Ph.D/Izumi Kohara,RN,Ph.D,CCRP. |
iPLAS Trial Office
Jichi Medical University, Department of Obstetrics and Gynecology
3311-1 Yakushiji ,Shimotsuke-city Tochigi, 329-0498 Japan
0285-58-7376
fujiwara@jichi.ac.jp
Gynecologic Oncology Trial and Investigation Consortium
Gynecologic Oncology Trial and Investigation Consortium
Non profit foundation
NO
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)
2011 | Year | 04 | Month | 22 | Day |
Unpublished
Completed
2011 | Year | 04 | Month | 04 | Day |
2011 | Year | 04 | Month | 23 | Day |
2016 | Year | 11 | Month | 06 | Day |
2017 | Year | 02 | Month | 06 | Day |
2017 | Year | 05 | Month | 06 | Day |
2017 | Year | 08 | Month | 06 | Day |
2011 | Year | 04 | Month | 22 | Day |
2018 | Year | 08 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006500
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