Comparing surgery and imaging methods for staging cervical cancer

Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer

This study is testing whether using surgery or imaging methods to stage cervical cancer helps patients live longer and feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1956 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Chongqing University Cancer Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Chongqing, Chongqing Municipality)
• Trial ID: NCT05378087 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of surgery staging versus image staging in patients with locally advanced cervical cancer. Eligible participants will be assigned to either the image staging group, receiving standard chemoradiation, or the surgery staging group, undergoing lymph node dissection followed by chemoradiation. The primary goal is to determine which method leads to better progression-free survival and overall survival rates. This multicenter, prospective trial will provide insights into optimal staging approaches for this condition.

Who should consider this trial

Good fit: Ideal candidates include women with locally advanced cervical cancer who meet specific histopathological and staging criteria.

Not a fit: Patients with severe infections, liver disease, or other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival outcomes for patients with locally advanced cervical cancer.

How similar studies have performed: While there have been studies on staging methods, this specific comparison of surgery versus imaging in this context is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
3. Stage (FIGO2018): IB3, IIA2, IIB-IVA;
4. ECOG score: 0 \~ 1;
5. The expected survival \>6 months;
6. The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial.

Exclusion Criteria:

1. Activity or uncontrol severe infection;
2. Liver cirrhosis or other decompensated liver disease;
3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
4. Chronic renal insufficiency or renal failure;
5. Other malignancies were diagnosed within five years or needed treatments;
6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
7. The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
8. A history of pelvic artery embolization;
9. A history of pelvic radiotherapy;
10. A history of partial hysterectomy or radical hysterectomy;
11. A history of severe allergic reaction to platinum drugs;
12. The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
13. Patients who cannot understand the research regimen and refuse to sign the informed consent form;
14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Where this trial is running

Chongqing, Chongqing Municipality

• Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality, China (Recruiting)

Study contacts

• Principal investigator: Dongling Zou, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Dongling Zou, M.D.

Conditions Locally Advanced Cervical Cancer; surgery staging; image staging; Locally advanced cervical cancer; PFS