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  • 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)

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Clinical trial
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)
  1. Lukas Dostalek1,
  2. Ingo Runnebaum2,
  3. Francesco Raspagliesi3,
  4. Ignace Vergote4,5,
  5. Ladislav Dusek6,
  6. Jiri Jarkovsky7 and
  7. David Cibula1
  1. 1 Gynecologic Oncology Center, Department of Obstetrics and Gyncology, General Faculty Hospital and First Faculty of Medicine, Charles University, Prague, Czechia
  2. 2 Department of Gynecology, Jena University Hospital, Jena, Germany
  3. 3 Gynecologic Oncology, Isituto Tumori Milano, Milan, Italy
  4. 4 Department of Oncology, Laboratory of Tumor Immunology and Immunotherapy, ImmunOvar Research Group, Katholieke Universiteit Leuven, Leuven, Belgium
  5. 5 Department of Gynecology and Obstetrics, Leuven Cancer Institute, Katholieke Universiteit Leuven UZ Leuven, Leuven, Belgium
  6. 6 Institute of Health Information and Statistics of the Czech Republic, Prague, Czechia
  7. 7 Institute of Biostatistics and Analyses, Faculty of Medicine, Masaryk University, Brno, Czechia
  1. Correspondence to Dr David Cibula, Department of Obstetrics and Gynecology, University of Prague, Prague, Czech Republic; d_cibula{at}yahoo.com

Abstract

Background The management of patients with intraoperative detection of lymph node involvement remains controversial. The most significant aspect is the decision regarding the completion of the cervical procedure, such as hysterectomy, radical hysterectomy, or a fertility sparing procedure.

Primary objective The primary objective of the ABandoning RAd hyst in cerviX cancer (ABRAX) trial is to determine whether the completion of the cervical procedure (ie, radical hysterectomy) improves oncological outcome in patients with intraoperatively detected lymph node involvement before they are referred for definitive chemoradiation.

Study hypothesis We hypothesize that, in patients with intraoperative lymph node involvement, completion of radical hysterectomy or other cervical procedure does not improve the oncological outcome of definitive chemoradiation.

Trial design The ABRAX trial is a multicenter, retrospective, cohort study. Patients with negative lymph nodes in clinical staging, in whom lymph node involvement is detected intraoperatively, are included. Completion or abandonment of the planned cervical procedure stratifies the cohort into two subgroups in which oncological outcome and morbidity will be compared.

Major Inclusion/Exclusion criteria Patients with early stage (pT1a–pT2b) cervical cancer, who did not have positive lymph nodes on preoperative imaging, who were scheduled for primary surgical treatment, and in whom metastatic involvement of pelvic lymph node was found during surgery either as a grossly (macroscopically) involved or on intraoperative pathology assessment will be enrolled. Patients can be included irrespective of surgical approach (minimal invasive surgery or laparotomy) and type of cervical procedure performed (hysterectomy, radical hysterectomy, or a fertility sparing procedure).

Primary endpoint The primary endpoint of this retrospective study is a progression free survival in two subgroups with abandoned or completed cervical procedure followed by definitive chemoradiation in both groups.

Sample size The assumed sample size is 718 patients (in total for both groups).

Estimated dates for completing accrual and presenting results Estimated end of data collection: December 2019; estimated date of presenting results: Q2/3 2020.

Trial registration Clinicaltrials.gov: NCT04037124.

  • cervical cancer
  • sentinel lymph node and lympadenectomy
  • surgery
  • radiation

https://doi.org/10.1136/ijgc-2019-000890

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    Footnotes

    • Contributors LD: data curation; formal analysis; methodology; project administration; writing-original draft; writing-review and editing, investigation. IR: investigation. FR: investigation. IV: investigation. LD: data curation; formal analysis; methodology. JJ: data curation; formal analysis; methodology. DC: conceptualization; formal analysis; methodology; project administration; supervision; writing-review and editing; investigation.

    • Funding This work was supported by Charles University in Prague (UNCE 204065 and PROGRES Q28/LF1) and by a grant from the Czech Research Council (No 16-31643A, NV19-03-00023).

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon request