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)

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) - 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

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000194

Enrollment

200

Registered

2005-09-12

Start date

2002-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Patients with cervical cancer

Interventions

A: neoadjuvant chemotherapy + radical hysterectomy B: Radical hysterectomy

Eligibility

Sex/Gender

Female

Inclusion criteria

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 80 torr, normal ECG 9) Written informed consent

Exclusion criteria

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 infectoin 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
progression-free survival, complication of surgery, completeness of radical hysterectomy, ommission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, adverse events	—

Countries

Japan

Contacts

Public ContactNoriyuki Katsumata ,MD

JCOG0102 Coordinating Office Medical Oncology Division, National Cancer Center Hospital

JCOG_sir@ml.jcog.jp

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026