Postoperative cervical cancer patients with high risk factors for relapse
Conditions
Interventions
Intensity modulated radiotherapy(IMRT) 50Gy/25fr
Sponsors
National Cancer Center Hospital, Tokyo, Japan.
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histologically confirmed squamous cell carcinoma, adenocarcinoma and adenosquamous cell carcinoma of cervix. 2)underwent radical hysterectomy and pelvic lymphadenectomy. 3)Histologically confirmed parametrium invasion or pelvic lymph node metastasis. 4) Age between 20 and 75 years at registration. 5) Performance status(ECOG) 0-2. 6)No history of radiotherapy or chemotherapy for abdominal region. 7)Not planned to use concurrent chemotherapy during radiotherapy. 8)Sufficient bone marrow functions should be confirmed by the clinical tests within 28 days before registration as follows: i)WBC:>=2,000/mm3 ii)neutrophil:>=1,500/mm3 iii)hemoglobin:>=8.0g/dL iv)blood platelet:>=100,000mm3 9)Written consent obtained.
Exclusion criteria
Exclusion criteria: 1) Patients with DM using continuous insulin or DM of poor control. 2) Patients with hypertension of poor control. 3) Patients with unstable angina or with myocardial infarction last 6 months. 4) Patients with active concomitant malignancy. 5) Patients with active infection requiring systemic therapy. 6) Pelvic infection of more than grade 3. 7) Patients with fever more than 38.0 degrees C at the registration. 8) Patients with psychological problems and inappropriate for entering this study. 9) Patients with ulcerative colitis or Crohn disease. 10) Patients with collagen disease such as SLE or scleroderma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of acute adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| In-pelvis progression free survival Progression free survival Overall survival Incidence and severity of chronic adverse events Percentage of accomplishment of treatment | — |
Countries
Japan
Outcome results
None listed