stage 1b2/2 cervical cancer
Conditions
Interventions
The Radical hysterectomy surgery after Irinotecan 60mg/m2 day 1,8+Nedaplatin 80mg/m2 day1 q3weeks 1-3 courses
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pathologicaly confirmed Cervi(Squamous cell carcinoma) 2)FIGO Stage1b2,2a(measurable lesion>=40mm by palpation or MRI)or 1b(measurable lesion>=20mm by palpation or MRI) 3)Measurable lesion by palpation or MRI 4)No prior chemotherapy 5)20 years-old<=age<=75 years-old 6)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 7)Able to completely have radical hysterectomy 8)Adequate bone marrow,cardiac,pulmonry functions(Lab data must be within 14 days from the registration) 1 Absolute neutrophil count:>= 2,000/mm3 2 Platelet count:>= 100,000/mm3 3 Hemoglobin:>= 9.0g/dL 4 AST/ALT:<100IU/l 5 Bilirubin:<1.5mg/dL 6 Serum creatinine: <1.2mg/dL 7 creatinine clearance >60ml/min 8 ECG Normal 9)Written informed consent
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tumor Response | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactKen Takizawa, M.D.
JGOG1065 Coordinating Office JAPANESE FOUNDATION FOR CANCER RESEARCH
Outcome results
None listed