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)
Overview
- Phase
- Phase 3
- Intervention
- radical hysterectomy
- Conditions
- Cervical Neoplasms
- Sponsor
- Haruhiko Fukuda
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- overall survival
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Haruhiko Fukuda
JCOG Data Center
Japan Clinical Oncology Group
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
Surgery
Intervention: radical hysterectomy
Chemotherapy + Surgery
Intervention: neoadjuvant chemotherapy + radical hysterectomy
Outcomes
Primary Outcomes
overall survival
Secondary Outcomes
- progression-free survival
- complication of surgery
- completeness of radical hysterectomy
- omission of postsurgical irradiation
- completeness of postsurgical irradiation
- response rate
- adverse events