Evaluating lymph node dissection for advanced cervical cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This national, multicenter, randomized clinical study aims to assess the efficacy of lymph node dissection in patients with stage IIICr cervical cancer. Participants will be randomly assigned to either a standard treatment group receiving chemoradiation or an experimental group undergoing lymph node dissection followed by chemoradiation. The study will measure progression-free survival (PFS) and overall survival (OS) to determine the potential benefits of the surgical intervention. The trial includes patients with specific histopathological types of cervical cancer and image-positive lymph nodes.

Why it matters

Who can join: the full rules

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

Where it's running

• Chongqing Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting

Study contacts

• Principal investigator: Dongling Zou, M.D. — Chongqing University Cancer Hospital
• Study coordinator: Dongling Zou, M.D.
• Email: cqzl_zdl@163.com
• Phone: 13657690699

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.