UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000001837
Receipt number 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 17:56:52

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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

Obstetrics 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 or person

Institute

Japan Clinical Oncology Group(JCOG)

Institute

Department

Personal name



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

Value
https://center6.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