Clinical trial · Interventional
Different Surgical Approaches in Patients of Early-stage Cervical Cancer
Randomized Trial of Different Surgical Approaches in Patients of Chinese Early-stage Cervical Cancer
- 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)
This multi-center, randomized controlled study aims to compare the survival outcomes (including overall survival, progression-free survival and disease-free survival between Chinese uterine cervical patients receiving different surgical routes (laparotomy and laparoscopy) for radical hysterectomy or trachelectomy, which is the primary study objective. All patients with uterine cervical cancer of FIGO stage IA1 (with lymphovascular space invasion), IA2 and IB1 will be included and randomized into two groups: laparotomy and laparoscopy groups for radical hysterectomy or trachelectomy. Secondary study objectives include: patterns of recurrence, treatment-associated morbidity (6 months from surgery), cost-effectiveness, pelvic floor function, and quality of life.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cost-Benefit Analysis | — | UNRESOLVED | — |
| Laparoscopy | — | UNRESOLVED | — |
| Laparotomy | — | UNRESOLVED | — |
| Morbidity | — | UNRESOLVED | — |
| Mortality | — | UNRESOLVED | — |
| Pelvic Floor Disorders | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Survival | — | UNRESOLVED | — |
| Uterine Cervical Neoplasm | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic radical hysterectomy | Procedure | — | UNRESOLVED |
| Laparoscopic radical trachelectomy | Procedure | — | UNRESOLVED |
| Laparotomic radical hysterectomy | Procedure | — | UNRESOLVED |
| Laparotomic radical trachelectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Laparotomic radical hysterectomy
- interventionNames
- Procedure: Laparotomic radical hysterectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparotomic radical trachelectomy
- interventionNames
- Procedure: Laparotomic radical trachelectomy
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic radical hysterectomy
- interventionNames
- Procedure: Laparoscopic radical hysterectomy
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix * FIGO stage IA1 (with lymphovascular space invasion), IA2 or IB1 * Type II or III radical hysterectomy or trachelectomy * Performance status of ECOG 0-1 * Aged 18 years or older * Signed an approved informed consents Exclusion Criteria: * Not satisfying any of the inclusion criteria
References
Publications (3)
- DERIVEDChao X, Li L, Wu M, Wu H, Ma S, Tan X, Zhong S, Lang J. Minimally invasive versus open radical trachelectomy for early-stage cervical cancer: protocol for a multicenter randomized controlled trial in China. Trials. 2020 Dec 14;21(1):1022. doi: 10.1186/s13063-020-04938-3. PMID 33317612
- DERIVEDFerrandina G, Corrado G, Scambia G. Minimally invasive surgery and quality of life in cervical cancer. Lancet Oncol. 2020 Jun;21(6):746-748. doi: 10.1016/S1470-2045(20)30161-3. No abstract available. PMID 32502439
- DERIVEDChao X, Li L, Wu M, Ma S, Tan X, Zhong S, Lang J, Cheng A, Li W. Efficacy of different surgical approaches in the clinical and survival outcomes of patients with early-stage cervical cancer: protocol of a phase III multicentre randomised controlled trial in China. BMJ Open. 2019 Jul 29;9(7):e029055. doi: 10.1136/bmjopen-2019-029055. PMID 31362966