Clinical trial · Interventional
Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer
Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer
NCT05378087CI-TRIAL-00069243recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemoradiation | Radiation | — | UNRESOLVED |
| Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Image staging group
- description
- Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
- interventionNames
- Radiation: Concurrent chemoradiation
- type
- EXPERIMENTAL
- label
- Surgery staging group
- description
- Open/minimally invasive para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).
- interventionNames
- Procedure: Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Primary outcomes (1)
- measure
- PFS
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (12)
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- BACKGROUNDBhatla N, Berek JS, Cuello Fredes M, Denny LA, Grenman S, Karunaratne K, Kehoe ST, Konishi I, Olawaiye AB, Prat J, Sankaranarayanan R, Brierley J, Mutch D, Querleu D, Cibula D, Quinn M, Botha H, Sigurd L, Rice L, Ryu HS, Ngan H, Maenpaa J, Andrijono A, Purwoto G, Maheshwari A, Bafna UD, Plante M, Natarajan J. Revised FIGO staging for carcinoma of the cervix uteri. Int J Gynaecol Obstet. 2019 Apr;145(1):129-135. doi: 10.1002/ijgo.12749. Epub 2019 Jan 17. PMID 30656645
- BACKGROUNDMartinez A, Angeles MA, Querleu D, Ferron G, Pomel C. How should we stage and tailor treatment strategy in locally advanced cervical cancer? Imaging versus para-aortic surgical staging. Int J Gynecol Cancer. 2020 Sep;30(9):1434-1443. doi: 10.1136/ijgc-2020-001351. Epub 2020 Aug 11. PMID 32788263
- BACKGROUNDChoi HJ, Ju W, Myung SK, Kim Y. Diagnostic performance of computer tomography, magnetic resonance imaging, and positron emission tomography or positron emission tomography/computer tomography for detection of metastatic lymph nodes in patients with cervical cancer: meta-analysis. Cancer Sci. 2010 Jun;101(6):1471-9. doi: 10.1111/j.1349-7006.2010.01532.x. Epub 2010 Feb 11. PMID 20298252
- BACKGROUNDKang S, Kim SK, Chung DC, Seo SS, Kim JY, Nam BH, Park SY. Diagnostic value of (18)F-FDG PET for evaluation of paraaortic nodal metastasis in patients with cervical carcinoma: a metaanalysis. J Nucl Med. 2010 Mar;51(3):360-7. doi: 10.2967/jnumed.109.066217. Epub 2010 Feb 11. PMID 20150275
- BACKGROUNDGouy S, Seebacher V, Chargari C, Terroir M, Grimaldi S, Ilenko A, Maulard A, Genestie C, Leary A, Pautier P, Morice P, Deandreis D. False negative rate at 18F-FDG PET/CT in para-aortic lymphnode involvement in patients with locally advanced cervical cancer: impact of PET technology. BMC Cancer. 2021 Feb 6;21(1):135. doi: 10.1186/s12885-021-07821-9.