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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001837
Receipt No. R000002140
Scientific Title A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
Date of disclosure of the study information 2009/04/01
Last modified on 2014/12/04

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Basic information
Public title A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
Acronym A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
Scientific Title A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
Scientific Title:Acronym A PhaseII trial of oral etopocide and iv irinotecan for patients with platinum resistant and taxane pretreated ovarian cancer(JCOG0503)
Region
Japan

Condition
Condition platinum resistant and taxane pretreated ovarian cancer
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate safety and efficacy of oral etoposide and iv irinotecan for patients with platinum resistant and taxane pre-treated ovarian, tubal and peritoneal cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes response rate
Key secondary outcomes adverse event, progression free survival, overall survival

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 etoposide 50mg/m2, p.o., day 1-21, irinotecan 70mg/m2 iv, day1, 15, repeat every 28 days, up to 6cycles
Interventions/Control_2
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
75 years-old >=
Gender Female
Key inclusion criteria 1. Cytologically or histologically proven ovarian, tubal, ore peritoneal cancer
2. Platinum resistant disease
3. Taxne pretreated disease
4. Age: 20-75 years old
5. PS: 0-2
6. One of the followings, or both of them
i) patients have measurable lesion
ii) patients have asseable lesion with elevated CA125 (more than 70)
7. No prior treatment with irinotecan, topotecan, or etopocide
8. No prior radiation to abdomen
9. Oral intake without parental nutrition
10. One of the followings
i) no drainage to effusion, or ascites in last 28 days
ii) no effusion or ascites to be drainaged
11. One of the followings
i) no chemotherapy or surgery in last 28 days
ii) no hormonal or biologic therapy in last 14 days
12. Patients without sever organ dysfunction
13. Written informed concsent
Key exclusion criteria 1. Patients with a concomitant or prior invasive malignancy (except intramucosal malignancy which are curable with local therapy) who have had any evidence of the disease within the last 5 years
2. Patients who cannot undergo treatment due to the past history of mental disorder or the central nerve disorder
3. Women during pregnancy or breast-feeding
4. Patients who have been treated with the systemic steroids medication
5. Patients with active infection
6. Patients with uncontrollable hypertension
7. Patients with uncontrollable diabetes
8. Patients with history of myocardial infarction, unstable angina, or heart failure within six months
9. Patients with bowel obstruction
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuo Konishi
Organization Graduate school of medicine, Kyoto University
Division name Division of Gynecology and Obstetrics
Zip code
Address 54 Kawara-cho, Shogoin, Sakyo-ku, Kyoto,606-8507,Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koji Matsumoto
Organization JCOG0503 Coordinating Office
Division name Hyogo Cancer Center medical oncology division
Zip code
Address 13-70,Kitaouji-cho,Akashi,Hyogo 673-8558,Japan
TEL 078-929-1151
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 北海道大学病院(北海道)
札幌医科大学(北海道)
岩手医科大学(岩手県)
東北大学病院(宮城県)
筑波大学臨床医学系(茨城県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
埼玉医科大学総合医療センター(埼玉県)
東京慈恵会医科大学附属柏病院(千葉県)
国立がん研究センター中央病院(東京都)
がん・感染症センター都立駒込病院(東京都)
東京慈恵会医科大学附属病院(東京都)
がん研究会有明病院(東京都)
東京大学医学部(東京都)
順天堂大学医学部(東京都)
NTT東日本関東病院(東京都)
北里大学医学部(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
信州大学医学部(長野県)
愛知県がんセンター中央病院(愛知県)
名古屋大学医学部(愛知県)
京都大学医学部附属病院(京都府)
大阪市立大学医学部附属病院(大阪府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
大阪市立総合医療センター(大阪府)
近畿大学医学部堺病院(大阪府)
兵庫県立がんセンター(兵庫県)
鳥取大学医学部(鳥取県)
国立病院機構呉医療センター・中国がんセンター(広島県)
国立病院機構四国がんセンター(愛媛県)
国立病院機構九州がんセンター(福岡県)
久留米大学医学部(福岡県)
九州大学病院(福岡県)
佐賀大学医学部(佐賀県)
熊本大学医学部(熊本県)
鹿児島市立病院(鹿児島県)
琉球大学医学部(沖縄県)

Other administrative information
Date of disclosure of the study information
2009 Year 04 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/25449313
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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
2009 Year 01 Month 30 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2013 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 04 Month 01 Day
Last modified on
2014 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=R000002140

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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