Oncological Outcome After Completing or Abandoning (Radical) Hysterectomy in Patients With Cervical Cancer and Intraoperative Detection of LN Positivity
NCT ID: NCT04037124
Last Updated: 2022-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
718 participants
OBSERVATIONAL
2017-12-01
2020-12-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Minimally Invasive Surgery Versus Open Radical Hysterectomy in Presumably Early Stage Cervical Cancer: a Retrospective Multicenter Non-inferiority Study Comparing Overall and Progression-free Survival.
NCT07120529
Laparoscopic Approach to Cervical Cancer
NCT00614211
German-funded Laparoscopic Approach to Cervical Cancer
NCT06489795
Radical Versus Simple Hysterectomy and Pelvic Node Dissection With Low-risk Early Stage Cervical Cancer
NCT01658930
Laparoscopic vs Abdominal Radical Hysterectomy In Patients With Early Cervical Cancer
NCT01258413
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Data on the oncologic outcome of patients with LN involvement after radical hysterectomy and adjuvant radiotherapy are broadly available. Recent figures show five-year survival in stage IB at around 70-85 % \[2,3\]. In contrast, the data on patients in whom radical hysterectomy was abandoned due to intraoperative detection of LN involvement are scarce. Available literature mostly refers to small groups of cases with grossly involved LN detected during surgery \[4-7\].
The goal of this study is to obtain the best data available from an adequate number of patients treated by both types of management in the same period of time and to analyse the risks and benefits of the performance of radical hysterectomy if LN involvement is detected intraoperatively in spite of non-suspicious preoperative radiological assessment.
ABRAX is an international multicenter retrospective trial. Data of cervical cancer patients with preoperatively negative LN in whom nodal involvement is detected during operation will be evaluated. The protocol has been developed to be inclusive and reflect current clinical practice. All surgical approaches are eligible for the study. Lymph node infiltration can be detected either by intraoperative pathology assessment or by gross assessment (macroscopic suspicion has to be confirmed by the final histology). Sentinel or any other pelvic lymph node can be subject of intraoperative assessment. Any type of nodal metastasis (macrometastasis, micrometastasis ot isolated tumor cells) is considered a positive LN. All types of cervical procedures (such as conisation, simple hysterectomy, trachelectomy, any type radical hysterectomy or radical trachelectomy) are eligible for the trial and administration of neoadjuvant chemotherapy is not an exclusion criterion. The abandonment of planned cervical procedure depends solely on the decision of the surgeon and on local institutional guidelines. The completion or abandonment of cervical procedure stratifies the cohort in two subgroups.
The primary end-point is the progression free survival assessed separately in both subgroups. Prevalence of ≥ G2 treatment related morbidity (CTCAE), overall and pelvic progression free survival are the secondary end-points.
Oncological outcome will be stratified according to the prognostic parameters such as tumour size, number of involved LN, type of LN metastases, presence of LVSI (lymphovascular space invasion), tumor type, administration of neoadjuvant chemotherapy, performance of systematic pelvic lymphadenectomy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cervical procedure abandoned
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.
No interventions assigned to this group
Cervical procedure completed
Cervical procedure (hysterectomy, radical hysterectomy or fertility sparing treatment) is completed. Patient is referred for adjuvant chemoradiation.
Cervical procedure
simple hysterectomy, radical hysterectomy or fertility sparing surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cervical procedure
simple hysterectomy, radical hysterectomy or fertility sparing surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Negative pelvic LN
* LN involvement reported by the final histology but not detected during the surgery
* Unavailability of follow-up data
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
General University Hospital, Prague
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
David Cibula
Head of Gynecologic Oncology Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Czech Republic
Prague, MUDr., Czechia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Landoni 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.
Cibula 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.
Richard 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.
Potter 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.
Bremer 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.
Suprasert 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.
Gray HJ, Seifert E, Sal Y Rosas VG, Nicandri KF, Koh WJ, Goff BA. The abandoned radical hysterectomy for cervical cancer: clinical predictors and outcomes. Obstet Gynecol Int. 2010;2010:743794. doi: 10.1155/2010/743794. Epub 2010 Apr 28.
Cibula D, Dostalek L, Hillemanns P, Scambia G, Jarkovsky J, Persson J, Raspagliesi F, Novak Z, Jaeger A, Capilna ME, Weinberger V, Klat J, Schmidt RL, Lopez A, Scibilia G, Pareja R, Kucukmetin A, Kreitner L, El-Balat A, Pereira GJR, Laufhutte S, Isla-Ortiz D, Toptas T, Gil-Ibanez B, Vergote I, Runnenbaum I. Completion of radical hysterectomy does not improve survival of patients with cervical cancer and intraoperatively detected lymph node involvement: ABRAX international retrospective cohort study. Eur J Cancer. 2021 Jan;143:88-100. doi: 10.1016/j.ejca.2020.10.037. Epub 2020 Dec 5.
Dostalek L, Runnebaum I, Raspagliesi F, Vergote I, Dusek L, Jarkovsky J, Cibula D. Oncologic outcome after completing or abandoning (radical) hysterectomy in patients with cervical cancer and intraoperative detection of lymph node positivity; ABRAX (ABandoning RAd hyst in cerviX cancer). Int J Gynecol Cancer. 2020 Feb;30(2):261-264. doi: 10.1136/ijgc-2019-000890. Epub 2019 Nov 20.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ENGOT-Cx3/CEEGOG/ABRAX
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.