Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer

Recruiting Phase 3 Interventional Study
Cervical Cancer Cervix Cancer Cervix Neoplasm
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 – 70
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
365 (estimated)
Sponsor
Hospital do Coracao · Other
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About This Trial
This study hypothesizes that patients who persist with cell-free human papillomavirus deoxyribonucleic acid (cfHPV-DNA) plasma expression at the end of standard treatment, can derive the benefit of using adjuvant chemotherapy in locally advanced cervical cancer (CC). After standard treatment based on concomitant chemoradiotherapy regime, a qualitative and quantitative research of cfHPV-DNA in plas…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3 to IVA will be included prospectively. * Previous standard treatment based on concomitant chemoradiotherapy regimen. * Karnofsky performance status score ≥70, with estimated life expectancy ≥12 weeks, …
Contacts

Michelle S Almeida, PhD

11 999112805

malmeida@hcor.com.br

CONTACT

Rachel H Machado, MCS

11 30536611

rhelena@hcor.com.br

CONTACT