Status:
TERMINATED
A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer
Lead Sponsor:
Haruhiko Fukuda
Collaborating Sponsors:
Ministry of Health, Labour and Welfare, Japan
Conditions:
Cervical Neoplasms
Eligibility:
FEMALE
20-70 years
Phase:
PHASE3
Brief Summary
To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer
Detailed Description
We designed this randomized study to investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer. Patients with FIGO stage I/II with bulky disease are randomized...
Eligibility Criteria
Inclusion
- Untreated cervical cancer
- Pathologically diagnosed squamous carcinoma
- FIGO stage Ib2, IIa (\>4cm), and IIb
- Measurable lesions
- Possible to radical hysterectomy
- Age: 20 to 70 years
- PS: 0 and 1
- 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
- Written informed consent
Exclusion
- 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
- Women during pregnancy or breast-feeding
- Patients with psychiatric illness
- Patients who have active infection
- Patients who have uncontrolled diabetes or uncontrolled hypertension
- Patients who have positive HBs
- Patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months
- Patients with interstitial pneumonitis or pulmonary fibrosis
- Patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency
Key Trial Info
Start Date :
February 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00190528
Start Date
February 1 2002
End Date
February 1 2009
Last Update
September 22 2016
Active Locations (1)
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1
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 1040045