Uterine cervical cancer
Conditions
Interventions
Whole-pelvic radiotherapy: 45.0 Gy/25 fx
SBRT to the primary lesion: 21.0 Gy/3 fx
Sponsors
Murofushi Nemoto Keiko
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1) Pathological confirmation of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma originating from the cervical primary lesion. 2) Clinical staging is T1b1-3b, N0-2, M0. 3) ECOG Performance Status of 0-2. 4) No prior definitive treatment for cervical cancer (conization is excluded). 5) Age meets one of the following criteria: - 80 years or older: The patient has correctly understood the explanation of standard and experimental treatments and wishes to undergo the experimental treatment. - 70-79 years: Intracavitary brachytherapy is deemed unsuitable, as evidenced by any of the following: - Primary lesion: Maximum diameter >= 7 cm on MRI T2-weighted imaging (patients will be excluded from the study if whole-pelvic irradiation enables intracavitary brachytherapy, which will then be performed). - Comorbidities: Conditions such as uterine fibroids or dementia. - Anatomical issues: Vaginal stenosis or uterine prolapse that prevents insertion of a Cusco speculum (size S). - Refusal of intracavitary brachytherapy. - Other cases: Cases deemed unsuitable for intracavitary brachytherapy by the attending physician. 6) Written informed consent obtained from the patient. 7) Blood tests within 21 days before registration meeting all of the following criteria: - White blood cell count >= 3,000 /mm3. - Hemoglobin >= 10 g/dL (correction via transfusion is permitted). - Platelet count >= 100,000 /mm3. - Serum total bilirubin 10 mL/min. 8) Expected prognosis of at least one year.
Exclusion criteria
Exclusion criteria: 1) Presence of severe comorbidities, such as: - Uncontrolled heart disease - Uncontrolled hypertension - Uncontrolled diabetes mellitus - Psychiatric disorders - Refractory infections - Acute-phase peptic ulcer 2) Active collagen disease requiring steroid treatment. 3) Comorbid conditions associated with a high risk of secondary malignancy, such as basal cell nevus syndrome or Li-Fraumeni syndrome. 4) Any other cases deemed unsuitable for participation in the study by the attending physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate, 2-y locoregional control rate, 2-y discant recurrence-free rate, 2-y OS, Adverse effects, Health-related QOL | — |
Contacts
Public ContactKei Ito
Tokyo Metropolitan Komagome Hospital
Outcome results
None listed