Cervical cancer (Stage I B2 and I B3, FIGO 2018 classification)
Conditions
Interventions
For locally advanced cervical cancer (FIGO stage IB2 to IB3, 2018 classification) with a tumor size exceeding 2 cm, including squamous cell carcinoma, adenocarcinoma, and adenosquamous carcinoma, neoa
Sponsors
Nagao Shoji
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Inclusion criteria 1. Patients clinically diagnosed with stage IB2 or IB3 cervical cancer (FIGO 2018 classification). Diagnosis will be made comprehensively using pelvic examination, colposcopy, digital rectal examination, pelvic MRI, CT or PET-CT, transvaginal ultrasound, and other relevant diagnostic methods. 2. Patients with a confirmed pathological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. 3. Premenopausal patients. 4. Patients under 40 years of age. 5. Patients with adequate overall organ function (clinical tests must have been performed within 28 days prior to the planned surgery): Neutrophil count: >= 1,500 /mm3 Platelet count: >= 100,000 /mm3 AST (GOT), ALT (GPT): <= 100 IU/L Serum total bilirubin: < 1.5 mg/dl Serum creatinine: < 1.5 mg/dl Electrocardiogram: Normal or asymptomatic abnormalities that do not require treatment (no history of heart disease or severe arrhythmias). Peripheral neuropathy: Grade 1 or lower (CTCAE v5.0). 6. Patients who wish to preserve fertility. 7. Patients aged 18 and older who have received sufficient explanation regarding the study and, after fully understanding, provide voluntary written informed consent to participate.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Patients with HPV-independent cancer. 2. Patients with any active concomitant malignancy (synchronous malignancy or metachronous malignancy with a disease-free interval of less than 5 years. However, basal cell carcinoma and squamous cell carcinoma of the skin, as well as lesions judged to be cured by local treatment such as in situ carcinoma or mucosal carcinoma, are not considered active concomitant malignancies). 3. Patients with severe comorbidities (including severe cardiovascular diseases, cerebrovascular disorders, difficult-to-control diabetes or hypertension, pulmonary fibrosis, interstitial pneumonia, bleeding disorders, active peptic ulcers, or severe neurological disorders). 4. Patients with a history of hypersensitivity reactions related to the administration of formulations containing polyoxyethylene castor oil (e.g., Cremophor ELR) or castor oil derivatives (e.g., injectable vitamin preparations). 5. Patients with active infections requiring treatment. 6. Pregnant, breastfeeding patients, or patients with the possibility of pregnancy. 7. Minors and patients incapable of providing informed consent. 8. Other patients who are deemed unsuitable for inclusion in the study by the principal investigator or co-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterine preservation rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 2 year progression free survival rate 2 year overall survival rate (in all enrolled patients) Progression free survival Overall survival Female medical prognosis Rate of menstrual resumption, Rate of ovulation resumption Pregnancy rate Live birth rate, miscarriage and preterm birth rates Types, grades, and incidence rates of toxicity (using CTCAE version 5.0) | — |
Contacts
Public ContactNaoyuki Ida
Okayama University Hospital
Outcome results
None listed