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
- Diseases
- Cervical cancer
- 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
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Tacchini Coordinator of this site? Confirm its status | Bento Gonçalves | Brazil | Not yet recruiting |
| Centro Oncologico de Roraima, CECOR Coordinator of this site? Confirm its status | Boa Vista | Brazil | Not yet recruiting |
| Hospital de Base do Distrito Federal Coordinator of this site? Confirm its status | Brasília | Brazil | Not yet recruiting |
| Hospital Evangelico de Cachoeiro de Itapemirim Coordinator of this site? Confirm its status | Cachoeiro de Itapemirim | Brazil | Not yet recruiting |
| Centro de Atenção Integral a Saúde da Mulher, CAISM Coordinator of this site? Confirm its status | Campinas | Brazil | Not yet recruiting |
| Centro de Oncologia de Cascavel, CEONC Coordinator of this site? Confirm its status | Cascavel | Brazil | Not yet recruiting |
| União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN Coordinator of this site? Confirm its status | Cascavel | Brazil | Not yet recruiting |
| Hospital Geral de Caxias do Sul Coordinator of this site? Confirm its status | Caxias do Sul | Brazil | Not yet recruiting |
| Centro Integrado de Oncologia de Curitiba (CIONC) Coordinator of this site? Confirm its status | Curitiba | Brazil | Not yet recruiting |
| Catarina Pesquisa Clinica Coordinator of this site? Confirm its status | Itajaí | Brazil | Not yet recruiting |
| Hospital do Amor Coordinator of this site? Confirm its status | Jales | Brazil | Not yet recruiting |
| Hospital Unimed Coordinator of this site? Confirm its status | Joinville | Brazil | Recruiting |
| Hospital Bruno Born Coordinator of this site? Confirm its status | Lajeado | Brazil | Not yet recruiting |
| Centro Integrado de Pesquisa da Amazônia, CINPAM Coordinator of this site? Confirm its status | Manaus | Brazil | Recruiting |
| Hospital do Câncer de Muriaé Coordinator of this site? Confirm its status | Muriaé | Brazil | Recruiting |
| Liga Norte Riograndense Contra o Cancer Coordinator of this site? Confirm its status | Natal | Brazil | Not yet recruiting |
| Centro Gaúcho Integrado - Hospital Mae de Deus Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Not yet recruiting |
| Instituto Nacional Do Cancer (INCA) Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Recruiting |
| Hospital São Paulo, Unifesp Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Instituto Brasileiro de Combate ao Câncer, IBCC São Camilo Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Hospital da Mulher - SECONCI Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Hospital do Coração - Research Institute Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Centro de Estudos e Pesquisa de Hematologia, CEPHO Coordinator of this site? Confirm its status | São Paulo | Brazil | Not yet recruiting |
| Hospital Santa Marcelina Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Instituo de Câncer Brasil, ICB Coordinator of this site? Confirm its status | Taubaté | Brazil | Not yet recruiting |
| Hospital Samur Coordinator of this site? Confirm its status | Vitória da Conquista | Brazil | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.