Status and phase
Conditions
Treatments
About
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:
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:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
510 participants in 2 patient groups
There are currently no registered sites for this trial.
Start date
Dec 20, 2023 • 1 year and 1 month ago
Today
Jan 22, 2025
End date
Dec 01, 2031 • in 6 years
Lead Sponsor
Collaborating Sponsors
Gynecologic Cancer Intergroup (GCIG)
Multicenter Italian Trials in Ovarian cancer and gynecologic malignancies
Swiss GO Trial Group
ARCAGY/ GINECO GROUP
Institute of Cancer Research, United Kingdom
Hellenic Cooperative Oncology Group
Grupo Español de Investigación en Cáncer de Ovario
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal