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

Recruiting now · Phase 3

Conditions studied: Cervical Cancer, Cervix Cancer, Cervix Neoplasm

In brief

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.

Key facts

Study ID

NCT05764044

Run by

Hospital do Coracao

People needed

365

Starts

2024-03-27

Expected to finish

2026-12-31

Last updated by the study team

2024-07-30

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Hospital da Mulher - SECONCI — São Paulo, São Paulo, Brazil (enrolling)
• Hospital do Coração - Research Institute — São Paulo, São Paulo, Brazil (enrolling)
• Centro Integrado de Pesquisa da Amazônia, CINPAM — Manaus, Amazonas, Brazil (enrolling)
• Hospital do Câncer de Muriaé — Muriaé, Minas Gerais, Brazil (enrolling)
• Hospital Santa Marcelina — São Paulo, São Paulo, Brazil (enrolling)
• Instituto Nacional do Câncer, INCA — Rio de Janeiro, Rio de Janeiro, Brazil (enrolling)
• Hospital Unimed — Joinville, Santa Catarina, Brazil (enrolling)
• 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 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
• Centro de Atenção Integral a Saúde da Mulher, CAISM — Campinas, São Paulo, Brazil
• Hospital do Amor — Jales, 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
• Centro de Estudos e Pesquisa de Hematologia, CEPHO — São Paulo, São Paulo, Brazil
• Centro de Oncologia de Cascavel, CEONC — Cascavel, Paraná, Brazil
• Instituo de Câncer Brasil, ICB — Taubaté, São Paulo, Brazil
• União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN — Cascavel, Paraná, Brazil
• Centro Integrado de Oncologia de Curitiba, CIONC — Curitiba, Paraná, 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

Full record on ClinicalTrials.gov

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