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

Study 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.

Official Title
-----------------
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)

Conditions
-----------------
Cervical Neoplasms

Intervention / Treatment
-----------------
* Drug: neoadjuvant chemotherapy + radical hysterectomy
* Procedure: radical hysterectomy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Surgery<br> | Procedure: radical hysterectomy<br> <br> |
| Experimental: Chemotherapy + Surgery<br> | Drug: neoadjuvant chemotherapy + radical hysterectomy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free survival |  |  | 
| complication of surgery |  |  | 
| completeness of radical hysterectomy |  |  | 
| omission of postsurgical irradiation |  |  | 
| completeness of postsurgical irradiation |  |  | 
| response rate |  |  | 
| adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bleomycin, cervical cancer, drug therapy, cisplatin, mitomycin, vincristine