Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
Adjuvant Chemotherapy in Cell-free Human Papillomavirus Deoxyribonucleic Acid (cfHPV-DNA) Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (CC)
Hospital do Coracao
365 participants
Mar 27, 2024
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria7
- 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,
- Positive research for types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82 cfHPV-DNA in plasma at the end of chemoradiotherapy,
- Patients of child-bearing potential were obligated to use an approved contraceptive method during and for 3 months after the study;
- Agree with research procedures, by signing the Informed Consent Form (ICF).
Exclusion Criteria5
- Previous cervical cancer or other malignancies,
- Pregnant women,
- Inability to perform concurrent cisplatin based-chemoradiotherapy.
- Tumors containing different HPV genotypes
- Absence of anatomopathological examination to prove the diagnosis and/or staging examinations.
Interventions
Two additional cycles of cisplatin-based adjuvant chemotherapy 50mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 at every 21 days.
Patients will be followed with plasma cfDNA-HPV, computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.
Locations(26)
View Full Details on ClinicalTrials.gov
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NCT05764044