A Trial of Neoadjuvant Chemotherapy + Surgery vs. Surgery for Bulky Stage I/II Cervical Cancer

• Status: Terminated
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

To investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage I/II cervical cancer

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haruhiko Fukuda
• Collaborator: Ministry of Health, Labour and Welfare, Japan

Criteria

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

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 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