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

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ClinicalTrials.gov Identifier: NCT04037124
Recruitment Status : Recruiting
First Posted : July 30, 2019
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
David Cibula, General University Hospital, Prague

Brief Summary:

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.


Condition or disease Intervention/treatment
Uterine Cervical Neoplasms Procedure: Cervical procedure

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.

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Study Type : Observational
Estimated Enrollment : 718 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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)
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : September 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04037124


Contacts
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Contact: Lukas Dostalek, MD +420224967451 lukas.dostalek@vfn.cz
Contact: David Cibula, MD +420224967451 dc@davidcibula.cz

Locations
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Czechia
Gynecologic Oncology Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague, Czech Republic Recruiting
Prague, MUDr., Czechia, 12800
Contact: Lukas Dostalek, MD    +420224967451    lukas.dostalek@vfn.cz   
Sponsors and Collaborators
General University Hospital, Prague
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: David Cibula, Head of Gynecologic Oncology Center, General University Hospital, Prague
ClinicalTrials.gov Identifier: NCT04037124    
Other Study ID Numbers: ENGOT-Cx3/CEEGOG/ABRAX
First Posted: July 30, 2019    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Cibula, General University Hospital, Prague:
Cervical cancer
Lymph node involvement
Radical hysterectomy
Radiotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases