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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003036
Receipt No. R000003677
Scientific Title A phase ll study of adjuvant chemotherapy with Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage lb2 or lla node-positive cervical cancer
Date of disclosure of the study information 2010/01/14
Last modified on 2018/08/13

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Basic information
Public title A phase ll study of adjuvant chemotherapy with Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage lb2 or lla node-positive cervical cancer
Acronym A phase ll study of adjuvant chemotherapy for node-positive cervical cancer
Scientific Title A phase ll study of adjuvant chemotherapy with Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage lb2 or lla node-positive cervical cancer
Scientific Title:Acronym A phase ll study of adjuvant chemotherapy for node-positive cervical cancer
Region
Japan

Condition
Condition Stage lb2 lla cervical cancer with pelvic lymph node metastasis
Classification by specialty
Obsterics and gynecology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Both the beneficial effects and the adverse toxicities with adjuvant chemotherapy of Irinotecan(CPT-11) plus Nedaplatin(NDP) for node-positive cervival cancer are studied in a phasell setting
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Two-year relapse-free survival rate
Key secondary outcomes Incidence of morbidity
Completeness of chemothrapy
Overall survival in 5 years
Relapse-free survival in 5 years
Incidence of leg lymphedema

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Irinotecan 60mg/m2 day1,8+Nedaplatin 80mg/m2 day q4weeks 5cycles
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
70 years-old >=
Gender Female
Key inclusion criteria 1)Pathologicaly confirmed cervical cancer(squamous cell carcinoma)
2)FIGO Stagelb2 or lla,including pathological parametrium involvement
3)Completely have radical hysterectomy and pelvic lymph node metastasis
4)Tumor removed completely by surgery
5)No prior therapy
6)20years-old<=age<=70years-old
7)ECOG performance status of 0 to 1
8)Adequate bone marrow,cardiac,pulmonry functions
9)Patients homozygous for UGT1A1*1,or heterozygous for UGT1A1*28 or UGT1A1*6
10)Written informed consent
11)Able to have a chemothrapy within 6 weeks after surgery
Key exclusion criteria 1)Patients with paraaortic lymph node metastasis
2)Patients with positive histological margin
3)Patients with adnexal involvement
4)Patients with tumor extension to other organs
5) Patients with active infections
6) Patients with serious complications
7) Patients with active concomitant malignancy
8) Patients with interstitial pneumonia or pulmonary fibrosis
9) Patients with massive pleural, cardiac effusion, and/or ascites
10) Patients with coneraindication to CPT-11or NDP
11) Patients with diarrhea (watery stool)
12) Patients with intestinal paralysis or illeus
13) Patients with any history of serious drug reactions or hypersensitivity
14) Patients with HBs antigen
15)Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuhiro Takeshima, M.D.
Organization CANCER INSTITUTE HOSPITAL
Division name Department of Gynecology
Zip code
Address 3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL 03-3520-0111
Email jgog1067@jgog.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuhiro Takeshima, M.D.
Organization JGOG1067 Coordinating Office
Division name CANCER INSTITUTE HOSPITAL
Zip code
Address 3-8-31 Ariake, Koutou-ku, Tokyo, 135-8550 Japan
TEL 03-3520-0111
Homepage URL
Email jgog1067@jgog.gr.jp

Sponsor
Institute Japanese Gynecologic Oncology Group
Institute
Department

Funding Source
Organization Japanese Gynecologic Oncology Group
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 癌研究会有明(東京), 市立秋田総合(秋田), 京都市立(京都), 王子総合(東京), 市立函館(北海道), 市立貝塚(大阪), 千葉医療センター(千葉), 埼玉社会保険(埼玉), 広島大学(広島), 県立広島(広島), 中国労災(広島), 名古屋第二赤十字(愛知), 社会保険徳山中央(徳山), 山口赤十字(山口), 岩手医科大学(岩手), 済生会長崎(長崎), 弘前大学(青森), 長崎市立市民(長崎), 山田赤十字(三重), 東京歯科大学市川総合(千葉), 藤田保健衛生大学(愛知), 公立陶生(愛知), 長崎大学(長崎), 金沢医科大学(金沢), 関西労災(大阪), 大分大学(大分), 九州がんセンター(福岡), 三沢市立三沢(青森), 東北大学(宮城), 東海大学(神奈川), 九州医療センター(福岡), 千葉県がんセンター(千葉), 三重県立総合医療センター(三重), 東邦大学大橋(東京),高知医療センター(高知),大田原赤十字(栃木),獨協医科大学(埼玉),近江八幡市立総合医療センター(滋賀),聖隷浜松(静岡),都立駒込(東京),KKR札幌医療センター(北海道),防衛医科大学(東京),四国がんセンター(香川),京都第一赤十字(京都),JA北海道厚生連札幌厚生(北海道),国立鹿児島医療センター(鹿児島),久留米大学(福岡)三重中央医療センター(三重),JR札幌(北海道),京都府立与謝の海(京都),鹿児島市立(鹿児島),横浜市立市民(神奈川),東京医療センター(東京),東京女子医科大学東医療センター(東京),沖縄県立中部(沖縄),大分県済生会日田(大分),横浜市立大学附属(神奈川),大阪市立大学医学部附属(大阪),JA廣島総合(広島),豊見城中央(沖縄),北里大学(神奈川),新潟県立がんセンター新潟(新潟),県立塚口(兵庫),岐阜大学医学部附属(岐阜),愛知県がんセンター(愛知),聖マリア(福岡),小倉記念(福岡),慶應義塾大学(東京),近畿大学医学部附属(大阪),大阪府立成人病センター(大阪),函館五稜郭(北海道),自治医科大学附属(埼玉),自治医科大学付属さいたま医療センター(埼玉),旭川医科大学(北海道),埼玉県立がんセンター(埼玉),近畿大学医学部堺(大阪),東京慈恵会医科大学附属(東京),京都大学医学部付属(京都),静岡県立静岡がんセンター(静岡),国家公務員共済組合連合会立川(東京),筑波大学(茨城),信州大学(長野),東京女子医科大学(東京),神戸大学(兵庫)、九州大学(福岡),東京医科歯科大学(東京),兵庫県立がんセンター(兵庫),聖マリアンナ医科大学(東京),松阪中央総合病院(三重),北海道大学(北海道),尾道総合病院(広島),奈良県立奈良病院(奈良)
※文字数の関係で病院、附属病院省略



Other administrative information
Date of disclosure of the study information
2010 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.gynecologiconcology-online.net/article/S0090-8258(18)30286-5/fulltext
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
2009 Year 11 Month 17 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2016 Year 12 Month 01 Day
Date of closure to data entry
2017 Year 02 Month 01 Day
Date trial data considered complete
2017 Year 03 Month 01 Day
Date analysis concluded
2017 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 01 Month 14 Day
Last modified on
2018 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003677

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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