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

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 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,
* 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,
* Proper hematological, liver and kidney functions. Inclusion criteria will include absolute neutrophils count ≥1.5 x 109/L, platelets ≥100 x 10/L, serum bilirubin ≤ 2.0 x upper limit of normal (ULN), calculated creatinine clearance ≥50 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,
* Inability to perform concurrent cisplatin based-chemoradiotherapy.
* Tumors containing different HPV genotypes
* Absence of anatomopathological examination to prove the diagnosis and/or staging examinations.

Conditions4

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