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PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

Study acronym: PAROLA
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 26 words Show 4 more changesShow less
    • Secondary endpoints: details revised at 7 of 8 entries
    • Study sites revised (37)
    • Collaborators: details revised at 1 of 10 entries
    • Publications: details revised at 1 of 1 entry
  2. Study sites: 35 to 37v37
  3. Study sites: 34 to 35v36
  4. Site details revised at 1 of 34 sitesv35
  5. Publications: details revised at 1 of 1 entryv34
  6. Trial sites expanded: 30 → 34 locationsv33
  7. Site details revised at 1 of 30 sitesv32
  8. Primary completion date: Dec 2031 to Dec 20, 2033
    • Study completion date: Dec 2033 to Dec 20, 2033
    • Site contacts updated at 1 of 30 sites
    v31
  9. Site details revised at 2 of 30 sitesv30
  10. Study sites: 26 to 30v29
  11. Site contacts updated at 1 of 26 sitesv28
  12. Re-verified, no change to tracked fieldsv27
  13. Study sites: 24 to 26v26
  14. Site details revised at 1 of 24 sitesv25
  15. Eligibility criteria expanded, about 6 wordsv24
  16. Site details revised at 1 of 24 sitesv23
  17. Site details revised at 1 of 24 sitesv22
  18. Site details revised at 1 of 24 sitesv21
  19. Re-verified, no change to tracked fieldsv20
  20. Site details revised at 1 of 24 sitesv19
  21. Site details revised at 1 of 24 sitesv18
  22. Site details revised at 1 of 24 sitesv17
  23. Study sites revised (24)v16
  24. Site details revised at 1 of 24 sitesv15
  25. Site details revised at 1 of 24 sitesv14
  26. Primary completion date: Jun 2033 to Dec 2031v13 Show 5 more changesShow less
    • Primary endpoint revised
    • Study completion date: Jun 2033 to Dec 2033
    • Secondary endpoints: 4 to 8
    • Site details revised at 6 of 24 sites
    • Collaborators: 2 to 10
  27. Site details revised at 1 of 24 sitesv12
  28. Study sites: 20 to 24v11
  29. Study sites: 18 to 20v10
  30. Site details revised at 1 of 18 sitesv9
  31. Site details revised at 1 of 18 sitesv8
  32. Eligibility criteria expanded, about 8 words
    • Site details revised at 1 of 18 sites
    v7
  33. Start date changed from estimate of Dec 2023 to Dec 20, 2023v6
  34. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 18 of 18 sites
    v5
  35. Start date: Sep 2023 to Dec 2023
    • Eligibility criteria expanded, about 39 words
    v4
  36. Start date: Jun 2023 to Sep 2023v3
  37. Start date: Jan 2023 to Jun 2023v2 Show 5 more changesShow less
    • Study sites: 19 to 18
    • Primary and study completion dates: Jan 2033 to Jun 2033
    • Eligibility criteria expanded, about 102 words
    • Secondary endpoints: details revised at 1 of 4 entries
    • Study title revised
  38. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is an international, multicenter and randomized open-label phase III study designed to demonstrate, in patients with stage IIIC1 cervical cancer, whether para-aortic lymphadenectomy followed by tailored chemoradiation is associated with increased disease-free survival compared to patients staged with FDG-PET/CT only followed by chemoradiation. The planned sample size is 510; including 200 patients in France. In this trial, patients will be assigned in one of the two following treatments arms: * Arm A (control arm): Standard chemo-radiotherapy and brachytherapy according to EMBRACE II and ESGO/ESTRO recommendations. * Arm B (experimental arm): Pretherapeutic para-aortic lymphadenectomy followed by tailored chemo-radiotherapy and brachytherapy. Considering the changing standard treatment landscape of locally advanced cervical cancer, both arms (control arm and experimental arm) may also be treated according to the INTERLACE and KEYNOTE-A18 studies, if applicable, at the discretion of the attending physician. Each patient will be followed up for 5 years. A cost-utility study will be performed in patients included in France. Other countries could be involved in this specific study. It will assess the incremental cost-utility ratio (cost per QALY gained) of para-aortic lymphadenectomy followed by tailored chemo-radiation in patients with positive PALN compared to patients staged with PET/CT only followed by chemo-radiation. This study also has ancillary objectives: * Biologic: To study T cell exhaustion, immune changes during chemoradiation, HPV ctDNA dynamic evolution, and the par-aortic lymph node as a premetastatic niche. * Radiomics: To study the contribution of radiomics and FDG-PET/CT metabolic parameters to predict para-aortic lymph node involvement and clinical outcome. * Senti-PAROLA: To evaluate the accuracy (Sensitivity, specificity, positive and negative predictive value) of the para-aortic sentinel lymph node (SPA) for PALN staging, and to evaluate the prognostic value of low volume metastasis of SPA.
Trial Details
NCT Number NCT05581121
Lead Sponsor Institut Claudius Regaud
Collaborators: ARCAGY/ GINECO GROUP, European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Cancer Intergroup (GCIG), Grupo Español de Investigación en Cáncer de Ovario, Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies, Belgian Gynaecological Oncology Group, Swiss GO Trial Group, Institute of Cancer Research, United Kingdom, The Central and Eastern European Gynecologic Oncology Group, Hellenic Cooperative Oncology Group
Conditions
(from sponsor)		 Cervical Carcinoma, Adenocarcinoma, Adenosquamous Carcinoma
Related terms Adenocarcinoma, Carcinoma, Adenosquamous, Uterine Cervical Neoplasms
Enrollment 510 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov