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

Chongqing University Cancer Hospital

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Radiation: Standard chemoradiation±pembrolizumab; Procedure: Lymph node dissection; Radiation: Chemoradiation± pembrolizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04555226

CQGOG0103

Details and patient eligibility

About

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.

Full 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 ±pembrolizumab).

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

Enrollment: 452 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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. Active hepatitis B, Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease
4. Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressive medications). Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) were not counted as systemic therapies, and subjects were permitted to use these therapies
5. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
6. Chronic renal insufficiency or renal failure
7. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
8. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
9. Has had an allogenic tissue/solid organ transplant
10. A history of pelvic artery embolization
11. A history of pelvic radiotherapy
12. A history of partial hysterectomy or radical hysterectomy
13. A history of immunotherapy or undergoing immunotherapy
14. A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and/or any excipients
15. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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452 participants in 2 patient groups

Standard treatment group

Active Comparator group

Description:

Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).

Treatment:

Radiation: Standard chemoradiation±pembrolizumab

Experimental group

Experimental group

Description:

Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).

Treatment:

Radiation: Chemoradiation± pembrolizumab

Procedure: Lymph node dissection