A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
NCT ID: NCT00190528
Last Updated: 2016-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
200 participants
INTERVENTIONAL
2002-02-28
2009-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Surgery
radical hysterectomy
Chemotherapy + Surgery
neoadjuvant chemotherapy + radical hysterectomy
Interventions
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neoadjuvant chemotherapy + radical hysterectomy
radical hysterectomy
Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
2. Women during pregnancy or breast-feeding
3. Patients with psychiatric illness
4. Patients who have active infection
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
20 Years
70 Years
FEMALE
No
Sponsors
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Ministry of Health, Labour and Welfare, Japan
OTHER_GOV
Haruhiko Fukuda
OTHER
Responsible Party
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Haruhiko Fukuda
JCOG Data Center
Principal Investigators
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Toshiharu Kamura, MD, PhD
Role: STUDY_CHAIR
Kurume University
Locations
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National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
Countries
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Related Links
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Related Info
Other Identifiers
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C000000194
Identifier Type: -
Identifier Source: secondary_id
JCOG0102
Identifier Type: -
Identifier Source: org_study_id
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