Actively Recruiting
Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
Led by Hospital do Coracao · Updated on 2024-07-30
365
Participants Needed
26
Research Sites
144 weeks
Total Duration
On this page
Sponsors
H
Hospital do Coracao
Lead Sponsor
U
University of Sao Paulo
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with International Federation of Gynecology and Obstetrics (FIGO) 2018 stage IB3 to IVA cervical cancer
- Completed previous standard treatment based on concomitant chemoradiotherapy regimen
- Karnofsky performance status score 70 or higher, with estimated life expectancy of at least 12 weeks
- Immunocompetent
- Positive plasma test for specified cfHPV-DNA types at the end of chemoradiotherapy
- Adequate blood counts and liver and kidney function: absolute neutrophils count 1.5 x 10^9/L or higher, platelets 100 x 10^9/L or higher, serum bilirubin less than or equal to 2.0 times upper limit of normal, creatinine clearance 50 mL/min or higher, ALT, AST, and alkaline phosphatase less than or equal to 2.5 times upper limit of normal
- Patients of child-bearing potential must agree to use an approved contraceptive method during and for 3 months after the study
- Agree to research procedures and sign informed consent form
You will not qualify if you...
- Previous cervical cancer or other malignancies
- Pregnant women
- Unable to receive concurrent cisplatin-based chemoradiotherapy
- Tumors containing different HPV genotypes
- Lack of anatomopathological examination to confirm diagnosis or staging exams
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 26 locations
1
Centro Integrado de Pesquisa da Amazônia, CINPAM
Manaus, Amazonas, Brazil, 69.020-030
Actively Recruiting
2
Hospital Evangélico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, Brazil, 29.308-065
Not Yet Recruiting
3
Hospital Samur
Vitória da Conquista, Estado de Bahia, Brazil, 45.023-145
Not Yet Recruiting
4
Hospital de Base do Distrito Federal
Brasília, Federal District, Brazil, 70.335-900
Not Yet Recruiting
5
Hospital do Câncer de Muriaé
Muriaé, Minas Gerais, Brazil, 36.888-233
Actively Recruiting
6
Centro de Oncologia de Cascavel, CEONC
Cascavel, Paraná, Brazil, 85.803-760
Not Yet Recruiting
7
União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN
Cascavel, Paraná, Brazil, 85.810-031
Not Yet Recruiting
8
Centro Integrado de Oncologia de Curitiba, CIONC
Curitiba, Paraná, Brazil, 80810-050
Not Yet Recruiting
9
Instituto Nacional do Câncer, INCA
Rio de Janeiro, Rio de Janeiro, Brazil, 20.220-410
Actively Recruiting
10
Liga Norte Riograndense Contra o Câncer
Natal, Rio Grande do Norte, Brazil, 59.062-000
Not Yet Recruiting
11
Hospital Tacchini
Bento Gonçalves, Rio Grande do Sul, Brazil, 95.700-084
Not Yet Recruiting
12
Hospital Geral de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil, 95.070-561
Not Yet Recruiting
13
Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil, 95.900-010
Not Yet Recruiting
14
Centro Gaúcho Integrado Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil, 90.850- 170
Not Yet Recruiting
15
Centro Oncologico de Roraima, CECOR
Boa Vista, Roraima, Brazil, 69.304-015
Not Yet Recruiting
16
Catarina Pesquisa Clínica
Itajaí, Santa Catarina, Brazil, 88.301-220
Not Yet Recruiting
17
Hospital Unimed
Joinville, Santa Catarina, Brazil, 89.204-061
Actively Recruiting
18
Centro de Atenção Integral a Saúde da Mulher, CAISM
Campinas, São Paulo, Brazil, 13.083-881
Not Yet Recruiting
19
Hospital do Amor
Jales, São Paulo, Brazil, 15.706-396
Not Yet Recruiting
20
Hospital da Mulher - SECONCI
São Paulo, São Paulo, Brazil, 01.206-001
Actively Recruiting
21
Hospital do Coração - Research Institute
São Paulo, São Paulo, Brazil, 04.005-000
Actively Recruiting
22
Instituto Brasileiro de Combate ao Câncer, IBCC São Camilo
São Paulo, São Paulo, Brazil, 04.015-070
Not Yet Recruiting
23
Hospital São Paulo, Unifesp
São Paulo, São Paulo, Brazil, 04.024-002
Not Yet Recruiting
24
Hospital Santa Marcelina
São Paulo, São Paulo, Brazil, 08.270-120
Actively Recruiting
25
Centro de Estudos e Pesquisa de Hematologia, CEPHO
São Paulo, São Paulo, Brazil, 09.060-650
Not Yet Recruiting
26
Instituo de Câncer Brasil, ICB
Taubaté, São Paulo, Brazil, 12.030-200
Not Yet Recruiting
Research Team
M
Michelle S Almeida, PhD
CONTACT
R
Rachel H Machado, MCS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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