UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000194 |
|---|---|
| Receipt number | R000000247 |
| 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) |
| Date of disclosure of the study information | 2005/09/12 |
| Last modified on | 2014/02/21 14:22:30 |
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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
| Obstetrics 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
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/
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000247
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