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NCT05764044RecruitingPhase 3

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

Adjuvant Chemotherapy in Cell-free Human Papillomavirus Deoxyribonucleic Acid (cfHPV-DNA) Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (CC)

Source: ClinicalTrials.gov · Last updated 30 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
365 (estimated)
First submitted
1 Mar 2023
Start date
27 Mar 2024
Primary completion date
31 Dec 2026
Lead sponsor
Hospital do Coracao
NCT number
NCT05764044

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 365
  • From 27 Mar 2024 to the primary completion date, 31 Dec 2026
  • 26 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous cervical cancer or other malignancies,
  • Inability to perform concurrent cisplatin based-chemoradiotherapy.

Other

  • Pregnant women,
  • Tumors containing different HPV genotypes
  • Absence of anatomopathological examination to prove the diagnosis and/or staging examinations.

Who the study is looking for

  • 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).

Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Tacchini
Coordinator of this site? Confirm its status
Bento GonçalvesBrazilNot yet recruiting
Centro Oncologico de Roraima, CECOR
Coordinator of this site? Confirm its status
Boa VistaBrazilNot yet recruiting
Hospital de Base do Distrito Federal
Coordinator of this site? Confirm its status
BrasíliaBrazilNot yet recruiting
Hospital Evangelico de Cachoeiro de Itapemirim
Coordinator of this site? Confirm its status
Cachoeiro de ItapemirimBrazilNot yet recruiting
Centro de Atenção Integral a Saúde da Mulher, CAISM
Coordinator of this site? Confirm its status
CampinasBrazilNot yet recruiting
Centro de Oncologia de Cascavel, CEONC
Coordinator of this site? Confirm its status
CascavelBrazilNot yet recruiting
União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN
Coordinator of this site? Confirm its status
CascavelBrazilNot yet recruiting
Hospital Geral de Caxias do Sul
Coordinator of this site? Confirm its status
Caxias do SulBrazilNot yet recruiting
Centro Integrado de Oncologia de Curitiba (CIONC)
Coordinator of this site? Confirm its status
CuritibaBrazilNot yet recruiting
Catarina Pesquisa Clinica
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ItajaíBrazilNot yet recruiting
Hospital do Amor
Coordinator of this site? Confirm its status
JalesBrazilNot yet recruiting
Hospital Unimed
Coordinator of this site? Confirm its status
JoinvilleBrazilRecruiting
Hospital Bruno Born
Coordinator of this site? Confirm its status
LajeadoBrazilNot yet recruiting
Centro Integrado de Pesquisa da Amazônia, CINPAM
Coordinator of this site? Confirm its status
ManausBrazilRecruiting
Hospital do Câncer de Muriaé
Coordinator of this site? Confirm its status
MuriaéBrazilRecruiting
Liga Norte Riograndense Contra o Cancer
Coordinator of this site? Confirm its status
NatalBrazilNot yet recruiting
Centro Gaúcho Integrado - Hospital Mae de Deus
Coordinator of this site? Confirm its status
Porto AlegreBrazilNot yet recruiting
Instituto Nacional Do Cancer (INCA)
Coordinator of this site? Confirm its status
Rio de JaneiroBrazilRecruiting
Hospital São Paulo, Unifesp
Coordinator of this site? Confirm its status
São PauloBrazilNot yet recruiting
Instituto Brasileiro de Combate ao Câncer, IBCC São Camilo
Coordinator of this site? Confirm its status
São PauloBrazilNot yet recruiting
Hospital da Mulher - SECONCI
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Hospital do Coração - Research Institute
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Centro de Estudos e Pesquisa de Hematologia, CEPHO
Coordinator of this site? Confirm its status
São PauloBrazilNot yet recruiting
Hospital Santa Marcelina
Coordinator of this site? Confirm its status
São PauloBrazilRecruiting
Instituo de Câncer Brasil, ICB
Coordinator of this site? Confirm its status
TaubatéBrazilNot yet recruiting
Hospital Samur
Coordinator of this site? Confirm its status
Vitória da ConquistaBrazilNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.