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

NCT04037124CompletedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

General University Hospital, Prague

Enrollment

718

Start Date

2017-12-01

Completion Date

2020-12-01

Study Type

OBSERVATIONAL

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)

Interventions

Cervical procedure

Conditions

Uterine Cervical Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Progression free survival (PFS)

Compare progression-free survival in cervical cancer patients in whom LN involvement was intraoperatively detected and in whom cervical procedure was completed vs. abandoned.

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

Secondary Outcomes

Prevalence of treatment related morbidity

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.

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

Overall survival (OS)

Compare overall survival in cervical cancer patients in whom LN involvement was intraoperatively detected and in whom cervical procedure was completed vs. abandoned.

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

Pelvic progression free survival

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.

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

Locations

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, Czechia

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Linked Papers

2019-11-20

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)

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. 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. 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. 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. 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). 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. The assumed sample size is 718 patients (in total for both groups). Estimated end of data collection: December 2019; estimated date of presenting results: Q2/3 2020. Clinicaltrials.gov: NCT04037124.