Overview

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:

Participant gender:

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

Details

Lead Sponsor:

Hospital do Coracao

Collaborator:

University of Sao Paulo

Treatments:

Cisplatin
Gemcitabine