Cervical
Conditions
Interventions
Experimental group:Three-dimensional endoluminal combined interstitial implantation of cervical cancer with 3D printed template
Sponsors
The 10th Hospital of Southern Medical University (Dongguan People's Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age 18-75 years old (=18 years old, =75 years old); (2) Cervical cancer patients who have completed radical external beam radiation therapy for curative purposes; (3) Pre-brachytherapy assessment with MRI indicating a tumor size of =30mm in the longest diameter; or clear involvement of the parametrium/pelvic sidewall before external beam radiation therapy; or significant eccentricity of the local cervical tumor where the dose distribution of conventional treatment cannot cover adequately; (4) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. (5) Expected survival period is not less than 6 months; (6) No obvious active bleeding; (7) The total number of white blood cells is greater than 3 × 109/L; (8) The total number of platelets is greater than 80 × 109/L; (9) Voluntarily sign an informed consent form and be willing to accept 3D printed template guided post implantation treatment.
Exclusion criteria
Exclusion criteria: (1) Prior pelvic radiation therapy for pelvic tumors; (2) Severe non-surgical comorbidities or acute infections; (3) Pathological diagnosis identified as non-squamous cell carcinoma, such as cervical glandular carcinoma, adenosquamous carcinoma, neuroendocrine carcinoma, sarcoma, etc.; (4) Persistent vaginal bleeding or significant bleeding tendency; (5) Impaired hematopoietic system, liver, or kidney function. Evaluation criteria are as follows: Complete blood count: white blood cell count (WBC) <3.0×109/L, absolute neutrophil count (ANC) <1.5×109/L, platelet count (PLT) <80×109/L, hemoglobin (Hb) <90g/L; (6) Subjects with significant cardiac arrhythmia, myocardial ischemia, severe atrioventricular block, heart failure, or severe valvular heart disease; (7) Subjects with severe bone marrow failure; (8) Subjects with poorly controlled mental illness; (9) Subjects who are pregnant or breastfeeding; (10) Subjects who, in the opinion of the researchers, are not suitable for participation in this trial; (11) Subjects who are currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HRCTV D90(90% of the High risk clinical target volume );Dose of D2CC of rectum, bladder, small intestine, colon; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR(objective respnse rate);1yLC(1year of Local Control);1yPFS(1year of Progression-Free Survival);Safety; | — |
Countries
China
Contacts
Public ContactXuefang-Zhang
The 10th Hospital of Southern Medical University (Dongguan People's Hospital)
Outcome results
None listed