A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis

Chongqing University Cancer Hospital264 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

264

Conditions

Locally Advanced Cervical Cancer

Interventions

surgical stagingPROCEDURE

para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chongqing University Cancer Hospital

Chongqing, China

RECRUITING

Outcomes

Primary Outcomes

The accuracy of the prediction model

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.

Time frame: 2 years

Secondary Outcomes

PFS

Progression-free Survival

Time frame: 3 years

LRR

The local recurrence rate of para-aortic lymphatic drainage area

Time frame: 1 year

LRR

The local recurrence rate of para-aortic lymphatic drainage area

Time frame: 2 year

Central Contacts

Dongling Zou, M.D.

CONTACT

13657690699 cqzl_zdl@163.com

Data from ClinicalTrials.gov

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