Oncological Outcome After Completing or Abandoning (Radical) Hysterectomy in Patients With Cervical Cancer and Intraoperative Detection of LN Positivity (ABRAX)

August 7, 2022 updated by: David Cibula, General University Hospital, Prague

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The management of patients with intraoperative detection of lymph node (LN) involvement currently varies widely. Options include completing or abandoning radical hysterectomy, performing or abandoning pelvic lymph node dissection and even continuing with inframesenteric or infrarenal paraaortic lymph node dissection. The most significant aspect is the decision regarding the performance of radical hysterectomy, due to the high morbidity caused by combined treatment composed of radical parametrectomy and adjuvant radiotherapy in these patients - patients are referred to pelvic radiotherapy after distal ureters, bladder and rectum have been surgically dissected [1].

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.

Study Type

Observational

Enrollment (Actual)

718

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czechia
    • MUDr.
      • Prague, MUDr., Czechia, 12800
        • Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Czech Republic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Consecutive participant sampling of patients with pT1a - pT2b cervical cancer and no evidence of LN involvement in preoperative imaging who were referred for primary surgery with curative intent and in whom nodal involvement was discovered intraoperatively.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Cervical procedure completed
Cervical procedure (hysterectomy, radical hysterectomy or fertility sparing treatment) is completed. Patient is referred for adjuvant chemoradiation.
Procedure: Cervical procedure
simple hysterectomy, radical hysterectomy or fertility sparing surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 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
Compare progression-free survival in cervical cancer patients in whom LN involvement was intraoperatively detected and in whom cervical procedure was completed vs. abandoned.
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of treatment related morbidity
Time Frame: From date of surgery for cervical cancer until the date of last follow-up control or death from any cause, whichever came first, assessed up to 176 months
Compare treatment related morbidity in cervical cancer patients in whom LN involvement was intraoperatively detected and in whom cervical procedure was completed vs. abandoned. Only adverse events ≥ grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) will be reported and evaluated.
From date of surgery for cervical cancer until the date of last follow-up control or death from any cause, whichever came first, assessed up to 176 months
Overall survival (OS)
Time Frame: From date of surgery for cervical cancer until the date of last follow-up control or death from any cause, whichever came first, assessed up to 176 months
Compare overall survival in cervical cancer patients in whom LN involvement was intraoperatively detected and in whom cervical procedure was completed vs. abandoned.
From date of surgery for cervical cancer until the date of last follow-up control or death from any cause, whichever came first, assessed up to 176 months
Pelvic progression free survival
Time Frame: From date of surgery for cervical cancer until the date of first documented pelvic recurrence or date of death from any cause, whichever came first, assessed up to 176 months
Compare pelvic progression-free survival in cervical cancer patients in whom LN involvement was intraoperatively detected and in whom cervical procedure was completed vs. abandoned.
From date of surgery for cervical cancer until the date of first documented pelvic recurrence or date of death from any cause, whichever came first, assessed up to 176 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General University Hospital, Prague

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2017

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

December 1, 2020

Study Registration Dates

First Submitted

July 21, 2019

First Submitted That Met QC Criteria

July 27, 2019

First Posted (ACTUAL)

July 30, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 7, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ENGOT-Cx3/CEEGOG/ABRAX

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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