NCT04037124

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
718

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 21, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 30, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

July 21, 2019

Last Update Submit

August 7, 2022

Conditions

Uterine Cervical Neoplasms

Keywords

Cervical cancerLymph node involvementRadical hysterectomyRadiotherapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    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 (3)

  • Prevalence of treatment related morbidity

    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)

    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

    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

Study Arms (2)

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

Interventions

Cervical procedurePROCEDURE

simple hysterectomy, radical hysterectomy or fertility sparing surgery

Cervical procedure completed

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • Preoperative evidence of grossly involved LN
  • Negative pelvic LN
  • LN involvement reported by the final histology but not detected during the surgery
  • Unavailability of follow-up data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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., 12800, Czechia

Location

Related Publications (9)

  • 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.

    PMID: 9284774BACKGROUND

  • 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.

    PMID: 22120175BACKGROUND

  • 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.

    PMID: 18234297BACKGROUND

  • 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.

    PMID: 2323617BACKGROUND

  • 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.

    PMID: 1459328BACKGROUND

  • 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.

    PMID: 15882176BACKGROUND

  • 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.

    PMID: 20454444BACKGROUND

  • 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.

    PMID: 33290995DERIVED

  • 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.

    PMID: 31748245DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Gynecologic Oncology Center

Study Record Dates

First Submitted

July 21, 2019

First Posted

July 30, 2019

Study Start

December 1, 2017

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

August 9, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)