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New treatment option for Cervical Cancer
Official title Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer
ClinicalTrials.gov ID: NCT05764044
What this study is testing
What is cisplatin, gemcitabine?
cisplatin, gemcitabine is an investigational medicine, given as an once-weekly, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70, women only
You may be able to join 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...
You likely can't join 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.
See the full eligibility criteria
- 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. 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...
- 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Manaus, Amazonas, Brazil
- Cachoeiro de Itapemirim, Espírito Santo, Brazil
- Vitória da Conquista, Estado de Bahia, Brazil
- Brasília, Federal District, Brazil
- Muriaé, Minas Gerais, Brazil
- Cascavel, Paraná, Brazil
- Curitiba, Paraná, Brazil
- Rio de Janeiro, Rio de Janeiro, Brazil
- Natal, Rio Grande do Norte, Brazil
- Bento Gonçalves, Rio Grande do Sul, Brazil
- Caxias do Sul, Rio Grande do Sul, Brazil
- Lajeado, Rio Grande do Sul, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Boa Vista, Roraima, Brazil
- Itajaí, Santa Catarina, Brazil
- Joinville, Santa Catarina, Brazil
- Campinas, São Paulo, Brazil
- Jales, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Taubaté, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manaus, Amazonas, Brazil; Cachoeiro de Itapemirim, Espírito Santo, Brazil; Vitória da Conquista, Estado de Bahia, Brazil; Brasília, Federal District, Brazil; Muriaé, Minas Gerais, Brazil; Cascavel, Paraná, Brazil and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.