Squamous cell carcinoma of the uterine cervix, Stage IIB (>
Conditions
Interventions
None listed
Sponsors
Hospital of the National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Sciences and Technology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Squamous cell carcinoma of the uterine cervix 2. Stage IIB (>=4 cm in diameter) and IIIB disease 3. Age; 20-70 years 4. PS; WHO 0-2 5. No prior chemotherapy, radiotherapy, and surgery to the pelvis 6. Life expectancy; longer than 6 months 7. Adequate bone marrow, hepatic, and renal functions; WBC>=3000/mm3 Hb>=10 g/dl Platelet>=100,000/mm3 Total bilirubin<=1.5 mg/dl (<=25.65 umol/L) AST/ALT<=2 times upper limit of normal Serum creatinine<=1.5 mg/dl (<=132.6 umol/L) 8. Written informed consent 9. Diagnostic images (CT of the abdomen and pelvis is needed, MRI of the pelvis is recommended but not mandatory) before starting EBRT. 10. No PALN metastasis on CT. (> 1 cm in minimum diameter)
Exclusion criteria
Exclusion criteria: 1. Severe concomitant illness 2. History of other malignancies within the past 5 years except basal cell carcinoma or squamous cell carcinoma in-situ of the skin 3. Tumor with infiltration of lower 1/3 of the vagina 4. Patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-year overall survival rate, acute and late toxicities. | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactNoriyuki Okonogi
National Institutes for Quantum and Radiological Sciences and Technology Hospital of the National Institute of Radiological Sciences
Outcome results
None listed