A phase 2 neoadjuvant chemotherapy of Irinotecan (CPT-11) plus Nedaplatin (NDP) for stage 1b2 or 2 cervical cancer of the uterine cervix

UMIN ID: UMIN000000552

Registered date:21/12/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: stage 1b2/2 cervical cancer
• Date of first enrollment: 2006/12/01
• Target sample size: 65
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): The Radical hysterectomy surgery after Irinotecan 60mg/m2 day 1,8+Nedaplatin 80mg/m2 day1 q3weeks 1-3 courses

Outcome(s)

• Primary Outcome: Tumor Response
• Secondary Outcome: 1The number of courses whiche produced PR or CR 2Toxicity 3The chage of serum SCC level 4Completeness of surgery 5Pathological findings 6Difficaltiness of surgery:blood loss and operation time 7Complications of surgery 8Relapse-Free Survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Female
• Exclude criteria: 1)Patients with active infections 2)Patients with serious complications(cardiac disease,uncontrolled diabetes mellitus,malignant hypertension,hemorrhagic tendancy) 3)Patients with active concomitant malignancy 4)Patients with interstitial pneumonia or pulmonary fibrosis 5)Patients with massive pleural, cardiac effusion, and/or ascites 6)Patients with unstable angina,history of cardiac infarction within 6 months,or arrhythmia that requires medical treatment 7)Patients with coneraindication to CPT-11or NDP 8)Patients with diarrhea (watery stool) 9)Patients with intestinal paralysis or illeus 10)Patients during pregnancy or breast-feeding,or unwilling to the use of contraception 11)Patients with any history of serious drug reactions or hypersensitivity 12)Patients who are inappropriate to enter this study with any safety reasons,judged by the treating physician

Related Information

• Primary Sponsor: Japanese Gynecologic Oncology Group
• Source(s) of Monetary Support: Japanese Gynecologic Oncology Group