Clinical trial · Observational
Oncological Outcome After Completing or Abandoning (Radical) Hysterectomy in Patients With Cervical Cancer and Intraoperative Detection of LN Positivity
Oncological Outcome After Completing or Abandoning (Radical) Hysterectomy in Patients With Cervical Cancer and Intraoperative Detection of LN Positivity; ABRAX (ABandoning RAd Hyst in cerviX Cancer)
NCT04037124CI-TRIAL-00060188ABRAXcompletedClinicalTrials.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 ABRAX trial is multicentre retrospective cohort study. Included are patients with negative LN in clinical staging, in whom LN involvement is detected intraoperatively. Completion or abandonment of planned cervical procedure stratifies the cohort in two subgroups in which oncological outcome and morbidity will be compared. The investigators hypothesise that in patients with intraoperative LN involvement, a completion of radical hysterectomy or other cervical procedure does not improve oncological outcome of definitive chemoradiation.
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 |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cervical procedure | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cervical procedure abandoned
- description
- Cervical procedure (hysterectomy, radical hysterectomy or fertility sparing treatment) is abandoned due to intraoperatively reported lymph node matestasis. Patient is referred for primary (chemo)radiation.
- label
- Cervical procedure completed
- description
- Cervical procedure (hysterectomy, radical hysterectomy or fertility sparing treatment) is completed. Patient is referred for adjuvant chemoradiation.
- interventionNames
- Procedure: Cervical procedure
Primary outcomes (1)
- measure
- Progression free survival (PFS)
- timeFrame
- From date of surgery for cervical cancer until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 176 months
- description
- Compare progression-free survival in cervical cancer patients in whom LN involvement was intraoperatively detected and in whom cervical procedure was completed vs. abandoned.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma * Stage pT1a - pT2b * Patient referred for primary surgical treatment such as radical / simple hysterectomy or fertility-sparing procedure (FST) and LN staging * Intraoperative detection of LN involvement (any type of metastasis): * Macroscopic involvement = grossly involved lymph nodes (if confirmed by final pathology) OR Microscopic involvement = SLN / LN intraoperative pathologic evaluation (frozen section) * Follow-up data available for ≥ 2 years * Surgery performed between January 2005 and December 2015 Exclusion Criteria: * Preoperative evidence of grossly involved LN * Histologic subtypes other than those noted in the Inclusion criteria * Negative pelvic LN * LN involvement reported by the final histology but not detected during the surgery * Unavailability of follow-up data
References
Publications (9)
- BACKGROUNDLandoni F, Maneo A, Colombo A, Placa F, Milani R, Perego P, Favini G, Ferri L, Mangioni C. Randomised study of radical surgery versus radiotherapy for stage Ib-IIa cervical cancer. Lancet. 1997 Aug 23;350(9077):535-40. doi: 10.1016/S0140-6736(97)02250-2. PMID 9284774
- BACKGROUNDCibula D, Abu-Rustum NR, Dusek L, Zikan M, Zaal A, Sevcik L, Kenter GG, Querleu D, Jach R, Bats AS, Dyduch G, Graf P, Klat J, Lacheta J, Meijer CJ, Mery E, Verheijen R, Zweemer RP. Prognostic significance of low volume sentinel lymph node disease in early-stage cervical cancer. Gynecol Oncol. 2012 Mar;124(3):496-501. doi: 10.1016/j.ygyno.2011.11.037. Epub 2011 Nov 25. PMID 22120175
- BACKGROUNDRichard SD, Krivak TC, Castleberry A, Beriwal S, Kelley JL 3rd, Edwards RP, Sukumvanich P. Survival for stage IB cervical cancer with positive lymph node involvement: a comparison of completed vs. abandoned radical hysterectomy. Gynecol Oncol. 2008 Apr;109(1):43-8. doi: 10.1016/j.ygyno.2007.12.002. Epub 2008 Jan 29. PMID 18234297
- BACKGROUNDPotter ME, Alvarez RD, Shingleton HM, Soong SJ, Hatch KD. Early invasive cervical cancer with pelvic lymph node involvement: to complete or not to complete radical hysterectomy? Gynecol Oncol. 1990 Apr;37(1):78-81. doi: 10.1016/0090-8258(90)90312-9. PMID 2323617
- BACKGROUNDBremer GL, van der Putten HW, Dunselman GA, de Haan J. Early stage cervical cancer: aborted versus completed radical hysterectomy. Eur J Obstet Gynecol Reprod Biol. 1992 Nov 19;47(2):147-51. doi: 10.1016/0028-2243(92)90045-z. PMID 1459328
- BACKGROUNDSuprasert P, Srisomboon J, Charoenkwan K, Siriaungul S, Khunamornpong S, Siriaree S, Phongnarisorn C, Lorvidhaya V. Outcomes of abandoned radical hysterectomy in patients with stages IB-IIA cervical cancer found to have positive nodes during the operation. Int J Gynecol Cancer. 2005 May-Jun;15(3):498-502. doi: 10.1111/j.1525-1438.2005.15315.x. PMID 15882176