Cervical Cancer
Conditions
Interventions
A:MRgFUS combined with chemoradiation therapy (CRT)
B:chemoradiation therapy, CRT
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Cervical squamous cell carcinoma was diagnosed as cervical squamous cell carcinoma by cervical biopsy for the first diagnosis or recurrence, and was consulted by an associate pathologist; (1) The pathological type complies with the WHO (2014) classification of female reproductive organ tumors: squamous cell carcinoma; (2) Cervical cancer diagnosis is in line with FIGO's 2018 surgical pathological staging. Select the FIGO IIB-IVA stage confined to the pelvic cavity and the maximum tumor diameter range is 4-8cm; (3) Histologic Grade classification: in line with NCCN 2020 guidelines (Clinical Practice Guidelines in Oncology Cervical Cancer version 1. 2020-January 14, 2020, www.NCCN.org); 1) Grade cannot be assessed; 2) G1: Well differentiated; 3) G2: Moderately differentiated; 4) G3: Differentiated or undifferentiated (Poorly differentiated or undifferentiated); 2. The lesion is clearly visible on enhanced MRI and is in a treatable position: the shortest distance between the planned ablation of the disease and the unintended structure-the epidermis under the surface is 10.0 mm; 3. Sign the informed consent form; 4. The patient has good compliance.
Exclusion criteria
Exclusion criteria: 1. The tumor has distant metastasis, short life expectancy, poor physical fitness and unable to complete MRI examination: (1) Those who have metastases outside the pelvis. (2) There is no clear localized mass. (3) Patients with other malignant tumors. (4) The general condition is poor, and the remaining survival period is expected to not exceed 3 months. (5) KPS score 100 after medication, or uncontrolled hypertension, that is, systolic blood pressure>160 and/or diastolic blood pressure>90; (8) Severe diabetes with vascular disease; (9) Hemolytic anemia: hematocrit 250 lbs 4. MRI evaluation of lesions that are difficult to target before treatment: <1 cm from the skin; 5. Pregnant women, lactating women or postpartum women; 6. The patient is receiving or has been receiving anticoagulation therapy in the previous 14 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;Cervical tumor ablation volume;OS rate;Quality of life, QOL;Adverse reaction rate;Evaluation; | — |
Contacts
Public ContactWu Su-Fang
Shanghai General Hospital
Outcome results
None listed