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)

UMIN ID: C000000194

Registered date:12/09/2005

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with cervical cancer
• Date of first enrollment: 2002/02/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

A: neoadjuvant chemotherapy + radical hysterectomy
B: Radical hysterectomy

Outcome(s)

• Primary Outcome: overall survival
• Secondary Outcome: progression-free survival, complication of surgery, completeness of radical hysterectomy, ommission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 70years-old
• Gender: Female
• Exclude 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

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare
• Secondary ID(s): NCT00190528