Locally Advanced Cervical Cancer
Conditions
Brief summary
The goal of this prospective single-arm trial is to investigate the accuracy and feasibility of the para-aortic lymph node metastasis prediction model in locally advanced cervical cancer, as well as its impact on patients' prognosis. The main questions it aims to answer are: * Is the para-aortic lymph node metastasis prediction model accurate and feasible? * Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.
Interventions
PROCEDUREsurgical staging
para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy
Sponsors
Chongqing University Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA; * It was treated initially without surgical and chemotherapy. * Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology. * Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment. * ECOG score:0 \ 1. * The expected survival time\>6 months; * There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance.
Exclusion criteria
* History of immune disease who need to take immunosuppressive drugs. * History of serious mental illness and brain functional disorder. * Other malignancies were diagnosed within five years or needed treatments. * Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements. * Without surgical conditions: 1) Chronic renal insufficiency or renal failure; 2) Liver insufficiency; 3)Chronic lung disease with restrictive respiratory dysfunction; 4) Cardiac dysfunction (patients with relative and absolute contraindications to surgery after consultation by cardiac physicians. * Patients who cannot understand the research regimen and refuse to sign the informed consent form. * Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The accuracy of the prediction model | 2 years | The performance of the model was assessed with respect to discrimination which was measured by the concordance index and calibration which was assessed by the calibration curve, Hosmer-Lemeshow test and Brier score. The investigators will calculate respectively the sensitivity and 95% confidence interval (CI), specificity and 95% CI, positive likelihood ratios (LR+) and 95% CI, negative likelihood ratios (LR-) and 95% CI, and the Kappa value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 years | Progression-free Survival |
| LRR | 1 year | The local recurrence rate of para-aortic lymphatic drainage area |
Countries
China
Contacts
Primary ContactDongling Zou, M.D.
Outcome results
None listed