A Prospective Study on the Prediction Model of Para-aortic Lymph Node Metastasis
Study Details
Study Description
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:
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Is the para-aortic lymph node metastasis prediction model accurate and feasible?
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Whether the para-aortic lymph node metastasis prediction model can affect the prognosis of patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: experimental group locally advanced cervical cancer treated with surgical staging |
Procedure: surgical staging
para-aortic lymphadenectomy from the inferior mesenteric artery cranially to the aorta caudally via laparoscopy or laparotomy
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- PFS [3 years]
Progression-free Survival
- LRR [1 year]
The local recurrence rate of para-aortic lymphatic drainage area
- LRR [2 year]
The local recurrence rate of para-aortic lymphatic drainage area
Eligibility Criteria
Criteria
Inclusion Criteria:
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In 2018, the International Federation of Obstetrics and Gynecology (FIGO) stage was Ib3 IIA2-IVA;
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It was treated initially without surgical and chemotherapy.
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Squamous cell carcinoma, adenocarcinoma and adeno-squamous cell carcinoma were confirmed by histopathology.
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Pelvic MRI ± abdominal CT or MRI or PET/CT were performed before treatment.
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ECOG score:0 ~ 1.
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The expected survival time>6 months;
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There is no absolute contraindication of surgery and and chemoradiotherapy and the patients with good compliance.
Exclusion Criteria:
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History of immune disease who need to take immunosuppressive drugs.
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History of serious mental illness and brain functional disorder.
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Other malignancies were diagnosed within five years or needed treatments.
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Those who are unable or unwilling to accept surgical treatment/sign informed consent/comply with research requirements.
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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.
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Patients who cannot understand the research regimen and refuse to sign the informed consent form.
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Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chongqing University Cancer Hospital | Chongqing | China |
Sponsors and Collaborators
- Chongqing University Cancer Hospital
Investigators
- Study Director: Dongling Zou, M.D., Chongqing University Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CQGOG0109