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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Terminated |
Unique ID issued by UMIN | C000000194 |
Receipt No. | 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 |
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 |
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Condition | ||
Condition | Patients with cervical cancer | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Terminated | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
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Management information | |||||||
Registered date |
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Last modified on |
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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 |