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

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)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190528

Enrollment

200

Registered

2005-09-19

Start date

2002-02-28

Completion date

2009-02-28

Last updated

2016-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Neoplasms

Keywords

cervical cancer, drug therapy, cisplatin, bleomycin, mitomycin, vincristine

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.

Interventions

DRUGneoadjuvant chemotherapy + radical hysterectomy

PROCEDUREradical hysterectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
complication of surgery	—
completeness of radical hysterectomy	—
omission of postsurgical irradiation	—
progression-free survival	—
response rate	—
adverse events	—
completeness of postsurgical irradiation	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026