Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (AddChemo)
Cervical Cancer, Cervix Cancer, Cervix Neoplasm
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Human papillomavirus, HPV, Cervical cancer, Circulating free DNA, Adjuvant chemotherapy
Eligibility Criteria
Inclusion Criteria: International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3 to IVA will be included prospectively. Karnofsky performance status score ≥70, with estimated life expectancy ≥12 weeks, Immunocompetent, Positive research for types 16 or 18 cfHPV-DNA in plasma at diagnosis, Proper hematological, liver and kidney functions. Inclusion criteria will include absolute neutrophils count ≥1.5 x 109/L, platelets ≥100 x 10/L, hemoglobin ≥10,0 g/dL, serum bilirubin ≤ 2.0 x upper limit of normal (ULN), calculated creatinine clearance ≥60 mL/min and alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN. 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 Criteria: Previous cervical cancer or other malignancies, Pregnant women, Previous HPV vaccination with bivalent or superior vaccine, Period between start and end of chemoradiotherapy treatment superior to eight weeks, Inability to perform concurrent cisplatin based-chemoradiotherapy. Tumors containing different HPV genotypes of 16 or 18.
Sites / Locations
- Hospital do Coração - Research Institute
Arms of the Study
Arm 1
Arm 2
Other
Experimental
Control Arm (Standard of Care)
Experimental Arm
Patients will be followed with computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.
Receive two cycles of cisplatin-based adjuvant chemotherapy 50mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 at every 21 days. After that, 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.