Phase II trial of taxane compound and carboplatin in stage Ib-II uterine cervical nonsqumous cell carcinoma with risk factors

UMIN ID: UMIN000001539

Registered date:01/01/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Stage Ib- II patients with uterine cervical nonsquamous cell carcinoma with risk factors, including pelvic lymphnode involvement and/ or parametrial extension
• Date of first enrollment: 2008/04/01
• Target sample size: 90
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Adjuvant chemotherapy for stage Ib-II uterine cervical nonsquamous cell carcinoma with risk factor after radical hysterectomy

Outcome(s)

• Primary Outcome: 2-year Progression free survival
• Secondary Outcome: Drug adverse effect, Compliance

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1.Patients with fever over 38.0 2.Patients with infection or more than WBC:12,000/mm3 3.Patients with severe complications 4.Patients with double cancer 5.Patients with massive pleural effusion, ascites and pericardiac fluid need to continuous drainage 6.Patients with neuropathy more than grade 1 7.Patients with edema more than grade 1, except for cervical adenocarcinoma 8.Patients with hypersensitivity reactions to taxane compound, carboplatin or polysorbate 80 9.Patients received neoadjuvant chemotherapy 10.Patients judged as the exclusive case by the investigator

Related Information

• Primary Sponsor: Sankai Gynecologic Study Group(SGSG), Tohoku Gynecologic Cancer Unit(TGCU)
• Source(s) of Monetary Support: Advanced Clinical Research Organization