Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

Not Applicable

Recruiting

• Conditions: Locally Advanced Cervical Cancer
• Interventions: Procedure: Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation; Radiation: Concurrent chemoradiation

• Registration Number: NCT05378087
• Lead Sponsor: Chongqing University Cancer Hospital

Brief Summary

The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.

Detailed Description

All eligible patients will be divided into the following two treatment groups nonrandomly.

Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy).

Surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be conducted within 28 days postoperatively.)

Study Timeline

• Study First Submitted: 2022-05-12
• Study First Submitted QC: 2022-05-12
• Study First Posted: 2022-05-17
• Study Start: 2022-06-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-29
• Last Update Posted: 2023-08-31
• Primary Completion: 2027-04-30
• Study Completion: 2032-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1956

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgery staging group	Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation	Open/minimally invasive para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
Image staging group	Concurrent chemoradiation	Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Primary Outcome Measures

Name	Time	Method
PFS	3 years	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
Complication	1 year	Some conditions caused by surgery or chemoradiation.
OS	3 years and 5 years	3-year and 5-year Overall Survival

Trial Locations

Locations (1)

Chongqing University Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China