NCT05764044 Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
| NCT ID | NCT05764044 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hospital do Coracao |
| Condition | Cervical Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 365 participants |
| Start Date | 2024-03-27 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 365 participants in total. It began in 2024-03-27 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05764044 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Cervical Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05764044 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 365 participants.
Is NCT05764044 currently recruiting?
Yes, NCT05764044 is actively recruiting participants. Contact the research team at malmeida@hcor.com.br for enrollment information.
Where is the NCT05764044 trial being conducted?
This trial is being conducted at Manaus, Brazil, Cachoeiro de Itapemirim, Brazil, Vitória da Conquista, Brazil, Brasília, Brazil and 11 additional locations.
Who is sponsoring the NCT05764044 clinical trial?
NCT05764044 is sponsored by Hospital do Coracao. The trial plans to enroll 365 participants.
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