NCT05378087 Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer
| NCT ID | NCT05378087 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chongqing University Cancer Hospital |
| Condition | Locally Advanced Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,956 participants |
| Start Date | 2022-06-27 |
| Primary Completion | 2027-04-30 |
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 1,956 participants in total. It began in 2022-06-27 with a primary completion date of 2027-04-30.
⚠ 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
The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.
Eligibility Criteria
Inclusion Criteria: 1. The patients with good compliance, voluntarily signed the informed consent form and participated in the study. 2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma 3. Stage (FIGO2018): IB3, IIA2, IIB-IVA; 4. ECOG score: 0 \~ 1; 5. The expected survival \>6 months; 6. The result of a pregnancy test (serum or urine) within seven days must be negative for women of childbearing age, who must take contraception during the trial. Exclusion Criteria: 1. Activity or uncontrol severe infection; 2. Liver cirrhosis or other decompensated liver disease; 3. A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease; 4. Chronic renal insufficiency or renal failure; 5. Other malignancies were diagnosed within five years or needed treatments; 6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association); 7. The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive; 8. A history of pelvic artery embolization; 9. A history of pelvic radiotherapy; 10. A history of partial hysterectomy or radical hysterectomy; 11. A history of severe allergic reaction to platinum drugs; 12. The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis; 13. Patients who cannot understand the research regimen and refuse to sign the informed consent form; 14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Contact & Investigator
Dongling Zou, M.D.
PRINCIPAL INVESTIGATOR
Chongqing University Cancer Hospital
Frequently Asked Questions
Who can join the NCT05378087 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Locally Advanced 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 NCT05378087 currently recruiting?
Yes, NCT05378087 is actively recruiting participants. Contact the research team at cqzl_zdl@163.com for enrollment information.
Where is the NCT05378087 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT05378087 clinical trial?
NCT05378087 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 1,956 participants.
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