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)
20 Years
70 Years
Female
Cervical Neoplasms
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
overall survival
Principal Investigator
Toshiharu Kamura, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Kurume University
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
JCOG0102
NCT ID:
NCT00190528
Start Date:
February 2002
Completion Date:
February 2009
Related Keywords:
- Cervical Neoplasms
- cervical cancer
- drug therapy
- cisplatin
- bleomycin
- mitomycin
- vincristine
- Neoplasms
- Uterine Cervical Neoplasms
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