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NCT05764044: AddChemo

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

Recruiting now Phase 3 Last updated 30 July 2024
What this trial tests

Phase 3 trial testing cisplatin, gemcitabine in Cervical Cancer in 365 participants. Currently enrolling.

Timeline
27 March 2024
Primary endpoint
31 December 2026
31 December 2026

Quick facts

Lead sponsorHospital do Coracao
PhasePhase 3
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment365
Start date27 March 2024
Primary completion31 December 2026
Estimated completion31 December 2026
Sites26 locations across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Hospital do Coracao

Who can join

Adults 18 to 70, female only, with Cervical Cancer or Cervix Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Viral oncogenesis in cancer: from mechanisms to therapeutics.
    Xiao Q, Liu Y, Li T, Wang C, et al · · 2025 · cited 45× · PMID 40350456 · DOI 10.1038/s41392-025-02197-9

Verify or expand the search:

Other recruiting trials for Cervical Cancer

Currently open trials in the same condition.

Other Hospital do Coracao trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05764044.

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