Extra Chemotherapy Tested in Cervical Cancer Patients with Residual HPV DNA
Tests extra chemotherapy in women with locally advanced cervical cancer and HPV DNA in blood.
Plain-language title generated from the registry record
Registry title: Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
Key facts
- Where
- Bento Gonçalves, Boa Vista, Brasília, Cachoeiro de Itapemirim, Campinas, Cascavel, Caxias do Sul, Curitiba, Itajaí, Jales, Joinville, Lajeado, Manaus, Muriaé, Natal, Porto Alegre, Rio de Janeiro, São Paulo, Taubaté, and Vitória da Conquista, BrazilSee the 26 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT05764044, who can take part
Where in Brazil
- Hospital TacchiniBento Gonçalves, BrazilNot yet recruiting
- Centro Oncologico de Roraima, CECORBoa Vista, BrazilNot yet recruiting
- Hospital de Base do Distrito FederalBrasília, BrazilNot yet recruiting
- Hospital Evangelico de Cachoeiro de ItapemirimCachoeiro de Itapemirim, BrazilNot yet recruiting
- Centro de Atenção Integral a Saúde da Mulher, CAISMCampinas, BrazilNot yet recruiting
- Centro de Oncologia de Cascavel, CEONCCascavel, BrazilNot yet recruiting
- União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCANCascavel, BrazilNot yet recruiting
- Hospital Geral de Caxias do SulCaxias do Sul, BrazilNot yet recruiting
- Centro Integrado de Oncologia de Curitiba (CIONC)Curitiba, BrazilNot yet recruiting
- Catarina Pesquisa ClinicaItajaí, BrazilNot yet recruiting
- Hospital do AmorJales, BrazilNot yet recruiting
- Hospital UnimedJoinville, BrazilTaking people
- Hospital Bruno BornLajeado, BrazilNot yet recruiting
- Centro Integrado de Pesquisa da Amazônia, CINPAMManaus, BrazilTaking people
- Hospital do Câncer de MuriaéMuriaé, BrazilTaking people
- Liga Norte Riograndense Contra o CancerNatal, BrazilNot yet recruiting
- Centro Gaúcho Integrado - Hospital Mae de DeusPorto Alegre, BrazilNot yet recruiting
- Instituto Nacional Do Cancer (INCA)Rio de Janeiro, BrazilTaking people
- Centro de Estudos e Pesquisa de Hematologia, CEPHOSão Paulo, BrazilNot yet recruiting
- Hospital da Mulher - SECONCISão Paulo, BrazilTaking people
- Hospital do Coração - Research InstituteSão Paulo, BrazilTaking people
- Hospital Santa MarcelinaSão Paulo, BrazilTaking people
- Hospital São Paulo, UnifespSão Paulo, BrazilNot yet recruiting
- Instituto Brasileiro de Combate ao Câncer, IBCC São CamiloSão Paulo, BrazilNot yet recruiting
- Instituo de Câncer Brasil, ICBTaubaté, BrazilNot yet recruiting
- Hospital SamurVitória da Conquista, BrazilNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Hospital do Coracao
- Trial code
- NCT05764044
- Record updated
- 30 July 2024
- Original 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.Read full original descriptionShow less
Adjuvant Chemotherapy in Cell-free Human Papillomavirus Deoxyribonucleic Acid (cfHPV-DNA) Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (CC)
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.
Inclusion: 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: Previous cervical cancer or other malignancies,; Inability to perform concurrent cisplatin based-chemoradiotherapy; Pregnant women,; Tumors containing different HPV genotypes; Absence of anatomopathological examination to prove the diagnosis and/or staging examinations.