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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHospital do Coracao

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

365 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Hospital do Coracao

Lead sponsor

University of Sao Paulo

Collaborator