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

Launched by HOSPITAL DO CORACAO · Mar 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether adding extra chemotherapy can help women with locally advanced cervical cancer who still have a specific type of virus in their blood after receiving standard treatment. The trial focuses on patients who have tested positive for cell-free human papillomavirus DNA (cfHPV-DNA) in their plasma after completing chemoradiotherapy, which is a combination of chemotherapy and radiation therapy. These patients will be randomly assigned to either receive two additional cycles of chemotherapy or just be observed without further treatment. Researchers will keep track of their health through regular imaging scans and check-ups every four months.

To join this study, participants need to be women aged 18 to 75 who have been diagnosed with specific stages of cervical cancer (stages IB3 to IVA) and have completed standard treatment. They should also be in good general health, with certain laboratory test results meeting the trial's criteria. Women who are pregnant, have had other types of cancer, or cannot undergo the required treatments will not be eligible. Overall, this trial aims to find out if extra chemotherapy can improve outcomes for patients who still have signs of the virus after their initial treatment.

Gender

FEMALE

Eligibility criteria

• 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.