PARa-aOrtic LymphAdenectomy in locally advanced cervical cancer (PAROLA trial): a GINECO, ENGOT, and GCIG study

Int J Gynecol Cancer. 2023 Feb 6;33(2):293-298. doi: 10.1136/ijgc-2022-004223.

Abstract

Background: Positron emission tomography/computed tomography (PET/CT) fails to detect approximately 25% of aortic lymph node metastasis in patients with PET/CT stage IIIC1 cervical cancer. Surgical staging could lead to treatment modification and to improved para-aortic and distant control.

Primary objectives: To demonstrate if chemoradiation with tailored external beam radiation field based on surgical staging and pathologic examination of the para-aortic lymph node is associated with improved 3-year disease-free survival compared with patients staged with PET/CT staging only.

Study hypothesis: Surgical staging followed by tailored chemoradiation will improve disease-free survival while avoiding unnecessary prophylactic extended-field chemoradiation in patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 cervical cancer.

Trial design: This is an international multicenter, randomized, phase III study. Eligible patients will be randomized 1:1 between PET/CT staging followed by chemoradiation (control arm), or surgical staging followed by tailored chemo-radiation (experimental arm). Randomization will be stratified by tumor stage according to TNM classification, center, and adjuvant treatment.

Major inclusion/exclusion criteria: Main inclusion criteria are histologically proven PET/CT FIGO stage IIIC1 cervical cancer. Main exclusion criteria include unequivocal positive common iliac or para-aortic lymph node at pre-therapeutic imaging PET/CT.

Primary endpoints: The primary endpoint is disease-free survival defined as the time from randomization until first relapse (local, regional, or distant), or death from any cause.

Sample size: 510 eligible patients ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: The estimated date for completing accrual will be Q2 2027. The estimated date for presenting results will be Q4 2030.

Trial registration number: NCT05581121.

Keywords: cervical cancer; lymph nodes; radiotherapy, intensity-modulated.

Publication types

  • Randomized Controlled Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Female
  • Humans
  • Lymph Node Excision / methods
  • Lymph Nodes / pathology
  • Lymph Nodes / surgery
  • Lymphatic Metastasis / pathology
  • Neoplasm Recurrence, Local / pathology
  • Neoplasm Staging
  • Positron Emission Tomography Computed Tomography*
  • Retrospective Studies
  • Uterine Cervical Neoplasms* / pathology
  • Uterine Cervical Neoplasms* / surgery

Associated data

  • ClinicalTrials.gov/NCT05581121