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

RECRUITING

NCT04555226

NA

Sponsor: Chongqing University Cancer Hospital

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

452

Start Date

2021-01-11

Completion Date

2032-08

Last Updated

2025-09-02

Healthy Volunteers

No

Conditions

Cervical Cancer

Interventions

PROCEDURE

Lymph node dissection

Open/minimaly invasive pelvic and para-aortic lymph node dissection

RADIATION

Standard chemoradiation±pembrolizumab

1\. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 \< 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.

RADIATION

Chemoradiation± pembrolizumab

1\. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 \< 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.

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

Locations (1)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

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