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Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
Sponsor: Hospital do Coracao
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.
Official title: Adjuvant Chemotherapy in Cell-free Human Papillomavirus Deoxyribonucleic Acid (cfHPV-DNA) Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (CC)
Key Details
Gender
FEMALE
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
365
Start Date
2024-03-27
Completion Date
2026-12-31
Last Updated
2024-07-30
Healthy Volunteers
No
Interventions
cisplatin, gemcitabine
Two additional cycles of cisplatin-based adjuvant chemotherapy 50mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 at every 21 days.
Follow-up
Patients will be followed with plasma cfDNA-HPV, computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months.
Locations (26)
Centro Integrado de Pesquisa da Amazônia, CINPAM
Manaus, Amazonas, Brazil
Hospital Evangélico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Hospital Samur
Vitória da Conquista, Estado de Bahia, Brazil
Hospital de Base do Distrito Federal
Brasília, Federal District, Brazil
Hospital do Câncer de Muriaé
Muriaé, Minas Gerais, Brazil
Centro de Oncologia de Cascavel, CEONC
Cascavel, Paraná, Brazil
União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN
Cascavel, Paraná, Brazil
Centro Integrado de Oncologia de Curitiba, CIONC
Curitiba, Paraná, Brazil
Instituto Nacional do Câncer, INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil
Hospital Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Centro Gaúcho Integrado Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Centro Oncologico de Roraima, CECOR
Boa Vista, Roraima, Brazil
Catarina Pesquisa Clínica
Itajaí, Santa Catarina, Brazil
Hospital Unimed
Joinville, Santa Catarina, Brazil
Centro de Atenção Integral a Saúde da Mulher, CAISM
Campinas, São Paulo, Brazil
Hospital do Amor
Jales, São Paulo, Brazil
Hospital da Mulher - SECONCI
São Paulo, São Paulo, Brazil
Hospital do Coração - Research Institute
São Paulo, São Paulo, Brazil
Instituto Brasileiro de Combate ao Câncer, IBCC São Camilo
São Paulo, São Paulo, Brazil
Hospital São Paulo, Unifesp
São Paulo, São Paulo, Brazil
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil
Centro de Estudos e Pesquisa de Hematologia, CEPHO
São Paulo, São Paulo, Brazil
Instituo de Câncer Brasil, ICB
Taubaté, São Paulo, Brazil