Cervical cancer
Conditions
Interventions
None listed
Sponsors
Chiba University Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients meeting all criteria are eligible: Primary cervical cancer with squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma proven pathologically. Advanced staging (Nissan 2020, FIGO 2018): IB1-3, IIA1-2, IIB, IIIA, IIIB, IIIC. Pelvic lymph node metastases: significant enlargement of basilar ligament, closed, external iliac, internal iliac, common iliac, or sacral iliac nodes, or significant accumulation on PET-CT. Para-aortic lymph node metastases: enlargement of lymph nodes around the aorta/inferior vena cava (>1 cm) at the level of the left renal vein and aortic bifurcation or PET-CT accumulation. Brachytherapy not feasible due to: (1) Primary lesion >7 cm on MRI T2-weighted image. (2) Comorbidities: uterine fibroids or dementia. (3) Anatomical issues: narrow vagina, etc. (4) Difficulty in administering adequate sedation/analgesia. (5) Institutional difficulty in sedation/analgesia even after consultation. (6) Patient refusal of brachytherapy. (7) Other cases where brachytherapy is judged ineligible (e.g., very old age). *Two-step registration required if reason (1) is met. Age >=18 years. ECOG PS: 0-2. No history of pelvic radiotherapy. Informed consent obtained. Blood tests within 14 days before enrollment meet: WBC >=3000/mm3, Hb >=10 g/dL (correction acceptable), platelets >=100000/mm3, Serum total bilirubin <1.5x upper limit, Serum AST/ALT <3x upper limit, Serum creatinine <3.0 mg/dL, Creatinine clearance >10 mL/min
Exclusion criteria
Exclusion criteria: 1) Patients with serious complications. Difficult-to-control cardiac disease, hypertension, diabetes, psychosis, refractory infections, acute peptic ulcers, etc. 2) Patients with active multiple cancers diagnosed within 3 years. However, lesions equivalent to intraepithelial or intramucosal carcinoma that are considered curable by local treatment are not included in active overlapping cancer. 3) Patients who are pregnant, possibly pregnant, within 28 days postpartum, or lactating. 4) Other patients who are deemed by the investigator to be unsuitable for the safe conduct of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of dose-limiting toxicity (DLT) after one year of enrolment DLT is defined as. Grading is based on CTCAE version 5.0. Non-infectious cystitis, urinary retention, bladder perforation, or urinary fistula of Grade 3 or above-Rectal hemorrhage, rectal ulcer, ileus, small bowel perforation, rectal perforation, or rectal fistula of Grade 3 or above-Hematuria of Grade 4 or above-Diarrhea, small bowel mucositis or rectal mucositis of Grade 4 or above-Radiation dermatitis of Grade 4 or above (unexpected severe adverse reactions other than those listed above are also defined) (unexpected severe adverse reactions other than those listed above may also be considered DLT if they are considered clinically serious). | — |
Countries
Japan
Contacts
Public ContactMiho Watanabe
Chiba University Hospital Department of Radiology
Outcome results
None listed