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

Study Overview
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Brief Summary
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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
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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.)

Official Title
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Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer

Conditions
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Cervical Cancer

Intervention / Treatment
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* Procedure: Lymph node dissection
* Radiation: Standard chemoradiation
* Radiation: Chemoradiation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm ECOG score 0 1 Expected survival over 6 months 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 No surgical contraindication Exclusion Criteria: Activity or uncontrol severe infection Liver cirrhosis, Decompensated liver disease History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease Chronic renal insufficiency or renal failure Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure A history of pelvic artery embolization A history of pelvic radiotherapy A history of partial hysterectomy or radical hysterectomy A history of severe allergic reaction to platinum drugs During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard treatment group<br>Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy). | Radiation: Standard chemoradiation<br>* A point/HCR-CTV D90 ≥80Gy（+20%） Extended-field EBRT: image-positive common iliac lymph nodes with short diameter ≥10mm and/or image-positive para-aortic lymph node Target doses for the image-positive nodes can range from 55 to 60Gy Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week) CCRT will be completed in 56 days After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed.<br>|
| Experimental: Experimental group<br>Open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy). | Procedure: Lymph node dissection<br>* Open/minimaly invasive pelvic and para-aortic lymph node dissection<br>Radiation: Chemoradiation<br>* A point/HCR-CTV D90 ≥80Gy（+20%） Extended-field EBRT: Pathlogical positive para-aortic lymph node Target doese for pelvic and/or abdomal lymph nodes is usually 45Gy. After operation, the residual lymph node need to be labeled and the target doses for it ranges from 55-60Gy. Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week) CCRT will be completed in 56 days After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall survival | 3 and 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stage IIICr of cervical cancer, Lymph node dissection, Chemoradiation, PFS