Adjuvant Treatment In HPV-DNA Positive Patients: A Plasma Biomarker For Chemotherapy In Locally Advanced Cervical Cancer

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: Female

Summary

This study hypothesizes that patients who persist with HPV 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 HPV DNA in plasma of patients will be conducted. Those with a negative qualitative research result will leave the study. Patients who have positive research for plasma 16/18 HPV 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 (MR) of abdomen and pelvis and clinical and gynecological examination at every four months.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital do Coracao
• Collaborator: University of Sao Paulo
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Cervical cancer EC FIGO 2018 IB3 to EC IVA will be included prospectively.

• Karnofsky performance status score ≥70, with estimated life expectancy ≥12 weeks,

• Immunocompetent,

• Positive research for HPV DNA types 16 or 18 in cervical and plasma tumor material 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.