Locally advanced cervical cancer
Conditions
Interventions
Concurrent chemoradiotherapy: CCRT Cisplatin (40mg/m2, weekly, 5 courses) Radiothrapy: BED 74-78Gy10 External beam: whole pelvis 50-50.4Gy/25-28fr (CS after 30-41.4Gy) HDR-ICBT : 6Gy x 3-4 (
Sponsors
Japanese Gynecologic Oncology Group
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Pathologically confirmed cervix cancer 2)Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 3)20 years-old<=age<=75 years-old 4)FIGO Stage3a,3b,4a 5)No prior treatments 6)Adequate bone marrow,cardiac,pulmonry function Absolute neutrophil count: >= 2,000/mm3 Hemoglobin: >= 10.0g/dL Platelet count: >= 100,000/mm3 Bilirubin: <1.5mg/dL AST/ALT: <100 IU/l Serum creatinine: < 1.2mg/dL creatinine clearance > 50 ml/min ECG Normal 7)Written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients with stump cancer 2) Patients with active infections 3) Patients with hydronephrosis 4) Patients with unstable angina, history of cardiac infarction within 6 months, or arrhythmia that requires medical treatment 5) Patients with serious complications 6) Patients who previously received pelvic radiotherapy 7) Patients with active concomitant malignancy 8) Patients who have undergone surgical staging 9) Patients with psychiatric illness that would prevent informed consent 10) Patients during pregnancy or breast-feeding, or unwilling to the use of contraception 11)Patients who are inappropriate to enter this study with any safety reasons, judged by the treating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility, Toxicity, Tumor response, Overall survival | — |
Countries
Japan
Contacts
Public ContactTakafumi Toita
JGOG1066 Coordinating Office University of the Ryukyus
Outcome results
None listed