The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Procedure: Lymph node dissection; Radiation: Standard chemoradiation; Radiation: Chemoradiation

• Registration Number: NCT04555226
• Lead Sponsor: Chongqing University Cancer Hospital

Brief Summary

This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and/or OS with lymph node dissection before CCRT when compared to CCRT.

Detailed Description

All eligible patients will be equally randomized between the 2 following treatment groups (stratified factors: whether para-aortic lymph nodes were image-positive):

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

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

Study Timeline

• Study First Submitted: 2020-09-14
• Study First Submitted QC: 2020-09-14
• Study First Posted: 2020-09-18
• Study Start: 2021-01-11
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-04
• Last Update Posted: 2023-09-07
• Primary Completion: 2024-08
• Study Completion: 2029-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 452

Inclusion Criteria

1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
2. Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm
3. ECOG score 0~1
4. Expected survival over 6 months
5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
6. No surgical contraindication

Exclusion Criteria

1. Activity or uncontrol severe infection
2. Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
4. Chronic renal insufficiency or renal failure
5. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. A history of pelvic artery embolization
8. A history of pelvic radiotherapy
9. A history of partial hysterectomy or radical hysterectomy
10. A history of severe allergic reaction to platinum drugs
11. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Lymph node dissection	Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
Standard treatment group	Standard chemoradiation	Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
Experimental group	Chemoradiation	Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Primary Outcome Measures

Name	Time	Method
PFS	2 years	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
OS	3 and 5 years	Overall survival

Trial Locations

Locations (1)

Chongqing Cancer Hospital; 🇨🇳 Chongqing, Chongqing, China