UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A phase ll study of adjuvant chemotherapy with Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage lb2 or lla node-positive cervical cancer
Title of the study (Brief title)	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	Nobuhiro Takeshima, M.D.
Organization	CANCER INSTITUTE HOSPITAL
Division name	Department of Gynecology
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	Nobuhiro Takeshima, M.D.
Organization	JGOG1067 Coordinating Office
Division name	CANCER INSTITUTE HOSPITAL
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 11 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.gynecologiconcology-online.net/article/S0090-8258(18)30286-5/fulltext
Results
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