NCT04555226 The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)
| NCT ID | NCT04555226 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chongqing University Cancer Hospital |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 452 participants |
| Start Date | 2021-01-11 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 452 participants in total. It began in 2021-01-11 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Dongling Zou, M.D.
PRINCIPAL INVESTIGATOR
Chongqing University Cancer Hospital
Frequently Asked Questions
Who can join the NCT04555226 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04555226 currently recruiting?
Yes, NCT04555226 is actively recruiting participants. Contact the research team at cqzl_zdl@163.com for enrollment information.
Where is the NCT04555226 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT04555226 clinical trial?
NCT04555226 is sponsored by Chongqing University Cancer Hospital. The principal investigator is Dongling Zou, M.D. at Chongqing University Cancer Hospital. The trial plans to enroll 452 participants.
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