Evaluating lymph node dissection for advanced cervical cancer treatment
Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer
NA · Chongqing University Cancer Hospital · NCT04555226
This study is testing whether adding lymph node surgery to standard treatment can help people with advanced cervical cancer live longer and have fewer problems with their disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 452 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Chongqing University Cancer Hospital (other) |
| Drugs / interventions | pembrolizumab, chemotherapy, immunotherapy |
| Locations | 1 site (Chongqing, Chongqing Municipality) |
| Trial ID | NCT04555226 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with stage IIICr cervical cancer who meet specific histopathological and health criteria.
Not a fit: Patients with severe infections, liver disease, or other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved survival rates for patients with advanced cervical cancer.
How similar studies have performed: Previous studies have shown promising results with similar surgical interventions in cancer treatment, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chongqing, Chongqing Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cervical Cancer, Stage IIICr of cervical cancer, Lymph node dissection, Chemoradiation, PFS