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 plasma of patients will be conducted. Patients who have positive research for plasma cfHPV-DNA at the end of chemoradiotherapy treatment will be randomized to receive two additional cycles of adjuvant chemotherapy or observation. Patients will be followed with conduction of computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.
Eligibility criteria
Qualifiers
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,
Immunocompetent,
Disqualifiers
Previous cervical cancer or other malignancies,
Pregnant women,
Inability to perform concurrent cisplatin based-chemoradiotherapy.
Tumors containing different HPV genotypes
Trial design
Treatments tested in this trial
- cisplatin, gemcitabine
- Follow-up
Treatment groups
Sponsors and collaborators
Hospital do Coracao
Lead sponsor
University of Sao Paulo
Collaborator