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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)

Phase 3
Conditions
Patients with cervical cancer
Registration Number
JPRN-C000000194
Lead Sponsor
Japan Clinical Oncology Group(JCOG)
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
Female
Target Recruitment
200
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
overall survival
Secondary Outcome Measures
NameTimeMethod
progression-free survival, complication of surgery, completeness of radical hysterectomy, ommission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, adverse events
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