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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000003670
Receipt No. R000004449
Scientific Title A Randomized Phase II/III Trial of Tri-weekly Intravenous versus Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel for Newly Diagnosed Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Date of disclosure of the study information 2010/06/01
Last modified on 2020/12/04

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Basic information
Public title A Randomized Phase II/III Trial of Tri-weekly Intravenous versus Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
for Newly Diagnosed Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Acronym IntraPeritoneal therapy for Ovarian Cancer with Carboplatin Trial
Scientific Title A Randomized Phase II/III Trial of Tri-weekly Intravenous versus Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
for Newly Diagnosed Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Scientific Title:Acronym IntraPeritoneal therapy for Ovarian Cancer with Carboplatin Trial
Region
Japan Asia(except Japan) North America

Condition
Condition Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the efficacy and safety of tri-weekly intravenous versus tri-weekly intraperitoneal Carboplatin both in combination with weekly intravenous Paclitaxel in newly diagnosed epithelial Ovarian, Fallopian tube, and primary peritoneal cancer.
Basic objectives2 Others
Basic objectives -Others To evaluate efficacy and safety of IP Carboplatin therapy for Ovarian, Fallopian tube, and primary peritoneal cancer.
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes PhaseII - Adverse event
PhaseIII - Progression Free Survival (PFS)
Key secondary outcomes Overall Suvival
Tumor Response
Adverse event
Treatment completion rate
Quality of Life
Cost effective

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 Tri-weekly Intravenous Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
Interventions/Control_2 Tri-weekly Intraperitoneal Carboplatin Both in Combination with Weekly Intravenous Paclitaxel
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) Patient assumed to have a stage II-IV epithelial ovarian, Fallopian tube, or primary peritoneal cancer as a pre-surgery diagnosis
2) Patient scheduled to undergo laparotomy
(*Both optimal and suboptimal patients will be eligible to the study)
3) ECOG Performance Status: 0-2
4) Patient consented to place the IP implantable port system, if assigned to IP treatment regimen
5) Patient expected to receive the first study treatment within 8 weeks after the comprehensive staging surgery
6) Reasonable organ function: Must be assessed within 28 days prior to Laparotomy
7) Patient expected to survive longer than 3 months from the starting date of the protocol therapy
8) Age: 18 or older
9) Patient must have signed informed consent.
Key exclusion criteria 1) Patients assumed to have a borderline malignancy of the ovary, fallopian tube, or primary peritoneal cancer
2) Patients who have received previous chemotherapy or radiation therapy to treat the current disease
3) Patients who have a synchronous malignancy or who have been progression-free less than 5 years for a metachronous malignancy (Patients with basal and squamous cell carcinoma of the skin, as well as carcinoma in situ, and intramucosal carcinoma cured by local treatment, are eligible for the study)
4) Patients with serious medical complications, such as serious heart disease, cerebrovascular accidents, uncontrolled diabetes mellitus, uncontrolled hypertension, pulmonary fibrosis, interstitial pneumonitis, active bleeding, an active gastrointestinal ulcer, or a serious neurological disorder
5) Patients who have had a hypersensitivity reaction to polyoxyethylated or hydrogenated castor oil
6) Patients with a pleural effusion requiring continuous drainage
7) Patients with an active infection requiring antibiotics
8) Patients who are pregnant, nursing or of child-bearing potential
9) Patients with evidence upon physical examination of brain tumor and any brain metastases
10) Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
11) Patients with any signs/symptoms of interstitial pneumonia
Target sample size 654

Research contact person
Name of lead principal investigator
1st name Keiichi
Middle name
Last name Fujiwara
Organization Saitama Medical University International Medical Center
Division name Department of Gynecologic Oncology
Zip code 350-0197
Address 1397-1 Yamane,Hidaka-City Saitama 350-1298
TEL 042-984-4111
Email iPocc@insti.kitasato-u.ac.jp

Public contact
Name of contact person
1st name Syoji
Middle name
Last name Nagao
Organization Hyogo Cancer Center
Division name Department of Gynecology
Zip code 673-0021
Address 13-70, Kitaoji-cho, Akashi-shi, Hyogo, 673-8558,Japan
TEL 078-929-1151
Homepage URL
Email iPocc@insti.kitasato-u.ac.jp

Sponsor
Institute Gynecologic Oncology Trial and Investigation Consortium /Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s) Gynecologic Oncology Trial and Investigation Consortium/Japanese Gynecologic Oncology Group

IRB Contact (For public release)
Organization Saitama Medical University IRB
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel 049-276-1662
Email tokutei@saitama-med.ac.jp

Secondary IDs
Secondary IDs YES
Study ID_1 NCT01506856
Org. issuing International ID_1 Clinical.gov
Study ID_2 jRCTs031180141
Org. issuing International ID_2 Japan Registry of Clinical Trials
IND to MHLW

Institutions
Institutions 埼玉医科大学国際医療センター(埼玉県)
自治医科大学付属病院(栃木県)
独立行政法人国立病院機構四国がんセンター(愛媛県)
東北大学病院(宮城県)
新潟県立がんセンター 新潟病院(新潟県)
鳥取市立病院(鳥取県)
群馬大学医学部附属病院(群馬県)
広島県厚生農業協同組合連合会 広島総合病院(広島県)
市立三次中央病院(広島県)
筑波大学附属病院(茨城県)
新潟大学医歯学総合病院(新潟県)
市立貝塚病院(大阪府)
埼玉医科大学総合医療センター(埼玉県)
横浜市立市民病院(神奈川県)
大阪国際がんセンター(大阪府)
奈良県立医科大学附属病院(奈良県)
公益財団法人がん研究会 有明病院(東京都)
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)
岩手医科大学附属病院(岩手県)
済生会長崎病院(長崎県)
慈恵医科大学病院(東京都)
慈恵医科大学付属柏病院(千葉県)
東京慈恵会医科大学附属第三病院(東京都)
群馬県立がんセンター(群馬県)
昭和大学病院(東京都)
兵庫医科大学病院(兵庫県)
独立行政法人国立病院機構 九州医療センター(福岡県)
東海大学医学部附属病院(神奈川県)
愛知県がんセンター(愛知県)
三重大学医学部附属病院(三重県)
大阪大学医学部附属病院(大阪府)
慶應義塾大学病院(東京都)
大阪医科大学(大阪府)
東京女子医科大学東医療センター(東京都)
静岡県立静岡がんセンター(静岡県)
福井大学医学部附属病院(福井県)
Korea Cancer Center Hospital(Korea)
KK Women's and Children's Hospital(Singapore)
京都府立医科大学病院(京都府)
兵庫県立がんセンター(兵庫県)
順天堂大学医学部附属順天堂医院(東京都)
Asan Medical Center(Korea)
Gangnam Severance Hospital in Korea(Korea)
Ewha Womans University Medical Center(Korea)
National University Hospital of Singapore(Singapore)
Queen Mary Hospital
弘前大学医学部附属病院(青森県)
東京大学医学部附属病院(東京都)
University of Otago - Christchurch/Christchurch Women's Hospital(New Zealand)
University of Pittsburgh(USA)
Shinchon Severance Hospital(Korea)

Other administrative information
Date of disclosure of the study information
2010 Year 06 Month 01 Day

Related information
URL releasing protocol http://studyweb.kitasato-ctcc.jp/
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 655
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 No longer recruiting
Date of protocol fixation
2010 Year 04 Month 26 Day
Date of IRB
2009 Year 09 Month 09 Day
Anticipated trial start date
2010 Year 05 Month 01 Day
Last follow-up date
2020 Year 02 Month 29 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 06 Month 30 Day
Date analysis concluded
2021 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2010 Year 05 Month 28 Day
Last modified on
2020 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004449

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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