Cervical cancer
Conditions
Interventions
External beam irradiation, Chemotherapy, Hybrid intracavitary/interstitial brachytherapy Patient enrollment period: 8 months after permission of the clinical trial for phase I study, 3 months inter
Sponsors
National Cancer Center Hospital, Department of Radiation Oncology
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Primary registration 1) Pathologically proven squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix 2) Age between 20 and 75 years old 3) FIGO stage IB2, IIA2, IIB, IIIA, IIIB, IVA(bladder invasion) 4) Patients for whom primary radiation therapy is planned 5) Tumor width greater than 5 cm assessed by pretreatment image examination 6) ECOG (Zubrod) performance status 0-2 7) No prior radiation therapy, chemotherapy, nor surgery for cervical cancer 8) Patients with sufficient organ function - neutrophil count greater than 2,000/mm3 - hemoglobin greater than 8g/dL - platelets greater than 50,000/mm3 - total bilirubin lower than 1.5mg/dL - AST (GOT) and ALT (GPT) lower than 100 IU/L -serum creatinine lower than 1.2mg/dL -creatinine clearance higher than 60mL/min 9) It is possible to stop taking or do not intake any anticoagulant or antiplatelet 10) No prior chemotherapy or no prior abdominopelvic irradiation 11) Patient must provide study-specific informed consent prior to study entry Secondary registration 1) Primary registration was already done 2) Tumor width greater than 4 cm assessed by pre-HBT image examination 3) ECOG (Zubrod) performance status 0-2 4) Neutrophil greater than 2,000/mm3 and platelet greater than 50,000/mm3
Exclusion criteria
Exclusion criteria: Primary registration 1) Patients with para-aortic lymph node metastasis. 2) Uncontrollable diabetes mellitus 3) Uncontrollable hypertension 4) Unstable angina pectoris or transmural myocardial infarction within the last 6 months 5) Prior invasive malignancy unless disease free for a minimum of 5 years. For example, carcinoma in situ of the breast, oral cavity, or esophagus are all permissible. 6) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 7) Body temperature greater than 38 degree Celsicus 8) Psychiatric comorbidities or problems hinders enrollment of the study 9) Active ulcerative colitis or Crohn's disease 10) Active systemic lupus erythematosus or scleroderma 11) Allergy to local anesthesia 12) Attending physician believes the patient is not suitable for the study 13) Positive for hepatitis B Surface antigen Secondary registration 1) Patients with FIGO IIIA and after 30/30.6 Gy of pelvic irradiation, still depth of the vaginal invasion exceeds 5 mm and cannot be handled with intracavitary brachytherapy 2) Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration 3) Body temperature greater than 38 degree Celsicus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I part: Rate of acute non-hematologic toxicity greater than grade 3 which is obviously attributed to hybrid brachytherapy Phase II part: 2-year pelvic relapse-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I part: Pelvic relapse-free survival, overall survival, progression-free survival Phase II part: dose constraint adherence rate of HBT, 2-year overall survival, 2-year progression-free survival, 2-year metastasis-free survival, the rate of acute toxicity, the rate of late toxicity | — |
Countries
Japan
Contacts
Public ContactNaoya Murakami
National Cancer Center Hospital Department of Radiation Oncology
Outcome results
None listed