UMIN-CTR Clinical Trial

Basic information
Public title	Phase III trial of neoadjuvant chemotherapy followed by surgery versus surgery alone for bulky stage I/II cervical cancer: Japan Clinical Oncology Group trial (JCOG0102)
Acronym	Phase III trial of neoadjuvant chemotherapy followed by surgery versus surgery alone for bulky stage I/II cervical cancer: Japan Clinical Oncology Group trial (JCOG0102)
Scientific Title	Phase III trial of neoadjuvant chemotherapy followed by surgery versus surgery alone for bulky stage I/II cervical cancer: Japan Clinical Oncology Group trial (JCOG0102)
Scientific Title:Acronym	Phase III trial of neoadjuvant chemotherapy followed by surgery versus surgery alone for bulky stage I/II cervical cancer: Japan Clinical Oncology Group trial (JCOG0102)
Region	Japan

Condition
Condition	Patients with cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical benefits of neadjuvant chemotherapy for bulky stage I/II cervical cancer
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	overall survival
Key secondary outcomes	progression-free survival, complication of surgery, completeness of radical hysterectomy, ommission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
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 Maneuver
Interventions/Control_1	A: neoadjuvant chemotherapy + radical hysterectomy
Interventions/Control_2	B: Radical hysterectomy
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) Untreated cervical cancer 2) Pathologically diagnosed squamous carcinoma 3) FIGO stage Ib2, IIa (>4cm), and IIb 4) Measurable lesions 5) Possible to radical hysterectomy 6) Age: 20 to 70 years 7) PS: 0 and 1 8) WBC > 3,000/mm3, Hb > 9.0g/dl, Platelet > 100,000 /mm3, SGOT/SGPT < 60 IU/L, T-Bil < 1.5 mg/dL, Cr < 1.2 mg/dL, PaO2 > 80 torr, normal ECG 9) Written informed consent
Key exclusion criteria	1) Patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer those are curable with local therapy 2) Women during pregnancy or breast-feeding 3) Patients with psychiatric illness 4) Patients who have active infectoin 5) Patients who have uncontrolled diabetes or uncontrolled hypertension 6) Patients who have positive HBs 7) Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months 8) Patients with interstitial pneumonitis or pulmonary fibrosis 9) Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Middle name Last name Toshiharu Kamura, MD, PhD
Organization	Kurume University
Division name	Obstetrics and Gynecology
Zip code
Address	67 Asahi-machi, Kurume-city, Fukuoka Prefecture 830-0011, JAPAN
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Noriyuki Katsumata ,MD
Organization	JCOG0102 Coordinating Office
Division name	Medical Oncology Division, National Cancer Center Hospital
Zip code
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045, JAPAN
TEL
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	YES
Study ID_1	NCT00190528
Org. issuing International ID_1	ClinicalTrials.gov by NLM
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions

Institutions

北海道大学医学部（北海道） 札幌医科大学（北海道） 東北大学医学部（宮城県） 筑波大学臨床医学系（茨城県） 群馬県立がんセンター（群馬県） 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） 国立がんセンター中央病院（東京都） 東京慈恵会医科大学附属病院（東京都） 癌研究会附属病院（東京都） 東京大学医学部（東京都） 順天堂大学医学部（東京都） 新潟県立がんセンター新潟病院（新潟県） 長岡赤十字病院（新潟県） 信州大学医学部（長野県） 愛知県がんセンター（愛知県） 国立病院機構名古屋医療センター（愛知県） 近畿大学医学部（大阪府） 大阪府立成人病センター（大阪府） 大阪市立医療センター（大阪府） 兵庫県立成人病センター（兵庫県） 鳥取大学（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） 鹿児島市立病院（鹿児島県）

Other administrative information
Date of disclosure of the study information	2005 Year 09 Month 12 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://www.ncbi.nlm.nih.gov/pubmed/23640393
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	Terminated
Date of protocol fixation	2001 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date	2002 Year 02 Month 01 Day
Last follow-up date	2009 Year 02 Month 01 Day
Date of closure to data entry	2009 Year 02 Month 01 Day
Date trial data considered complete	2009 Year 02 Month 01 Day
Date analysis concluded	2009 Year 02 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 09 Month 12 Day
Last modified on	2014 Year 02 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000247

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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