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

Phase 3

Terminated

• Conditions: Cervical Neoplasms
• Interventions: Procedure: radical hysterectomy; Drug: neoadjuvant chemotherapy + radical hysterectomy

• Registration Number: NCT00190528
• Lead Sponsor: Haruhiko Fukuda

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 to either neoadjuvant chemotherapy (BOMP: Cisplatin 14mg/m2 day 1-5, Bleomycin 7mg day 1-5, Mitomycin 7mg/m2 day 5, and Vincristine 0.7mg/m2 day every 21 days for 2-4 cycles followed by radical hysterectomy or radical hysterectomy alone. The primary endpoint is overall survival and the secondary endpoints are progression-free survival, complication of surgery, completeness of radical hysterectomy, omission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, and adverse events. A total 200 patients (100 per treatment arm) planned to accrue for this study within 5.5 years.

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Study Completion: 2009-02
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery	radical hysterectomy	-
Chemotherapy + Surgery	neoadjuvant chemotherapy + radical hysterectomy	-

Primary Outcome Measures

Name	Time	Method
overall survival

Secondary Outcome Measures

Name	Time	Method
progression-free survival
complication of surgery
completeness of radical hysterectomy
omission of postsurgical irradiation
completeness of postsurgical irradiation
response rate
adverse events

Trial Locations

Locations (1)

National Cancer Center Hospital; 🇯🇵 Chuo-ku, Tokyo, Japan