Clinical trial · Interventional
Sentinel Lymph Node Biopsy Versus Pelvic Lymphadenectomy in Early-stage Cervical Cancer (PHENIX/CSEM 010)
NCT02642471CI-TRIAL-00083765active not recruitingN/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 diagnostic value of sentinel lymph node biopsy in early-stage cervical cancer has been well studied. However, there were no randomized controlled study on comparing the long-term outcomes of sentinel lymph node biopsy and conventional procedure. The investigators perform a phase III, randomized controlled trial to determine whether pelvic lymphadenectomy can be replaced by sentinel lymph node biopsy in surgical treatment for patients with early-stage cervical cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Quality of Life | — | UNRESOLVED | — |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| no systematic pelvic lymphadenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Arm 1
- description
- patients with negative sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 1 or Arm 2 Arm 1: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 2: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
- interventionNames
- Procedure: no systematic pelvic lymphadenectomy
- type
- NO_INTERVENTION
- label
- Arm 2
- description
- patients with negative sentinel nodes confirmed by pathological examination of frozen section will be randomly assigned to Arm 1 or Arm 2 Arm 1: patients undergo radical hysterectomy±salpingo-oophorectomy (no systematic pelvic lymphadenectomy) Arm 2: patients undergo radical hysterectomy±salpingo-oophorectomy+pelvic lymph node dissection
- type
- EXPERIMENTAL
- label
- Arm 3
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with newly histologically confirmed cervical carcinoma * Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma * Original clinical stage must be FIGO (2018) stage IA1 (lymphovascular space involvement), IA2, IB1, IB2 and IIA1 * No suspected node should be found on imaging examination (RESIST 1.1) * Age between 18-65 * Patients must give signed informed consent * P.S status: 0-1 * Estimated survival time \> 3 months * Tumor diameter ≤ 3 cm Exclusion Criteria: * The presence of uncontrolled life-threatening illness * Receiving other ways of anti-cancer therapy * Investigator consider the patients can't finish the whole study * With normal liver function test (ALT、AST\>2.5×ULN) * With normal renal function test (Creatinine\>1.5×ULN) * WBC\<4,000/mm3 or PLT\<100,000/mm * The whole cervix has been occupied by tumor and there is no normal surface left for tracer injection * History of severe heart disease or deep venous thrombosis; 4) Presence or history of other malignant disease * Gestation or perinatal period * Intention to fertility preservation.
References
Publications (2)
- DERIVEDTu H, Huang H, Li Y, Chen X, Wang C, Zheng M, Zhang Y, Zhao W, Feng Y, Wan T, Huang Y, Yu A, Lu W, Xiao J, Shan W, Zhang P, Zhu C, Wang D, Zhou H, Li J, Kong B, Feng W, Wang X, Luo R, Huang X, Li J, Lin Z, Yao S, Liu J; PHENIX Investigators. Sentinel-Lymph-Node Biopsy Alone or with Lymphadenectomy in Cervical Cancer. N Engl J Med. 2025 Oct 16;393(15):1463-1474. doi: 10.1056/NEJMoa2506267. PMID 41092328
- DERIVEDTu H, Huang H, Xian B, Li J, Wang P, Zhao W, Chen X, Xie X, Wang C, Kong B, Xiao J, Zhang P, Liu J; PHENIX Investigators and the CSEM group. Sentinel lymph node biopsy versus pelvic lymphadenectomy in early-stage cervical cancer: a multi-center randomized trial (PHENIX/CSEM 010). Int J Gynecol Cancer. 2020 Nov;30(11):1829-1833. doi: 10.1136/ijgc-2020-001857. Epub 2020 Sep 24. PMID 32973117