PARa-aOrtic LymphAdenectomy in Locally Advanced Cervical Cancer

Recruiting Phase 3 Interventional Study
Cervical Carcinoma Adenocarcinoma Adenosquamous Carcinoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
510 (estimated)
Sponsor
Institut Claudius Regaud · Other
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About This Trial
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 pa…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Age ≥ 18 years at time of study entry 2. Newly diagnosed histologically proven cervical squamous carcinoma, adenocarcinoma, or adenosquamous tumor 3. FIGO stage IIIC1 (FIGO 2018) cervical cancer with FDG-PET/CT showing FDG-positive pelvic nodes and FDG-negative PALN including…
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