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Clinical Trial NCT05764044 (AddChemo) for Cervical Cancer, Cervix Cancer, Cervix Neoplasm is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Adjuvant Chemotherapy in cfHPV-DNA Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (AddChemo) Phase 3 365 Biomarker-Driven Randomized
Clinical Trial NCT05764044 (AddChemo) is designed to study Treatment for Cervical Cancer, Cervix Cancer, Cervix Neoplasm. It is a Phase 3 interventional study that is recruiting, having started on March 27, 2024, with plans to enroll 365 participants. Led by Hospital do Coracao, it is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on July 30, 2024.
Brief Summary
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 ...Show More
Detailed Description
A prospective, randomized, multicenter, national, superiority, parallel, clinical trial, design to evaluate the use of adjuvant chemotherapy in patients with locally advanced cervical cancer selected by cfDNA-HPV biomarker. Patients will be randomized by stratified randomization process to belong to one of the groups: control (Group B) or intervention (Group C), emphasizing homogeneity of risk factors between them. A...Show More
Official Title
Adjuvant Chemotherapy in Cell-free Human Papillomavirus Deoxyribonucleic Acid (cfHPV-DNA) Plasma Positive Patients: A Biomarker In Locally Advanced Cervical Cancer (CC)
Conditions
Cervical CancerCervix CancerCervix NeoplasmOther Study IDs
- AddChemo
- AddChemo CC Trial
NCT ID Number
Start Date (Actual)
2024-03-27
Last Update Posted
2024-07-30
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
365
Study Type
Interventional
PHASE
Phase 3
Status
Recruiting
Keywords
Human papillomavirus
HPV
Cervical cancer
Circulating free DNA
Adjuvant chemotherapy
HPV
Cervical cancer
Circulating free DNA
Adjuvant chemotherapy
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
OtherControl Arm (Standard of Care) Patients will be followed with plasma cfDNA-HPV, computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months. | Follow-up Patients will be followed with plasma cfDNA-HPV, computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months. |
ExperimentalExperimental Arm Receive two cycles of cisplatin-based adjuvant chemotherapy 50mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 at every 21 days. After that, patients will be followed with plasma cfDNA-HPV, computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months. | cisplatin, gemcitabine Two additional cycles of cisplatin-based adjuvant chemotherapy 50mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 at every 21 days. Follow-up Patients will be followed with plasma cfDNA-HPV, computed tomography (CT) scan of the thorax and magnetic resonance (MRI) of abdomen and pelvis and clinical and gynecological examination at every four months. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression free survival | Progression-free survival will be calculated from the date of randomization until the date of progression, whether local or distant, or death. | 120 days |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Overall survival | Pverall survival will be calculated from the date of randomization until death or last follow-up. Follow-up will be updated at each consultation and the following possibilities will be considered: living without disease, living with disease, death from cancer, death from another cause and loss of follow-up. | 120 days |
Overall response rate | Response assessment will be performed using RECIST 1.1 (2009) criteria through pelvic MRI. Thus, complete response (CR) will be considered the disappearance of all lesions. Partial response (PR), reduction (30%) in the sum of the largest diameters of target lesions, when compared to the initial examination. Disease progression (PD): increase (20%) in the sum of the largest diameters of the lesions, when compared to the initial examination or the appearance of new lesions. Stable disease: does not meet criteria for PR or PD. | 120 days |
Quality of life measures (EORTC QLQ-C30 and QLC-CX24) | Generic quality of life measures (EORTC QLQ-C30) will be assessed during medical consultations in this clinical study, considering that this questionnaire alone does not adequately assess specific treatment issues that affect the quality of life of women with cervical cancer, a QLQ-CX24 add-on module will also be applied. All questionnaires used in this study are self-administered, however, in those cases where the ability to understand, little education/illiteracy is considered low or when telephone monitoring is in force, the tests will be applied by the researchers, who will seek to read all the questions and help mark answers. | 21 to 120 days |
Toxicity according to the Common Terminology Criteria for Adverse Events v.5.0 | Toxicity will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (2017). Hematological (anemia, neutropenia, thrombocytopenia and febrile neutropenia), gastrointestinal (diarrhea, nausea and vomiting), renal (serum creatinine changes) and hepatic (AST and ALT changes) toxicities will be evaluated. Grade 1 and 2 toxicities, together, were considered mild and grade 3 and 4 toxicities were considered severe. | 7 to 120 days |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- 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).
- 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.
Hospital do CoracaoUniversity of Sao Paulo183 active studies to exploreStudy Central Contact
Contact: Michelle S Almeida, PhD, 11 999112805, [email protected]
Contact: Rachel H Machado, MCS, 11 30536611, [email protected]
26 Study Locations in 1 Countries
Amazonas
Centro Integrado de Pesquisa da Amazônia, CINPAM, Manaus, Amazonas, 69.020-030, Brazil
Patricia Serra, Contact, (92) 9130-8097, [email protected]
Gilmara Resende, Principal Investigator
Recruiting
Espírito Santo
Hospital Evangélico de Cachoeiro de Itapemirim, Cachoeiro de Itapemirim, Espírito Santo, 29.308-065, Brazil
Narelle Parmanhani, Contact, (28) 3522-5095, [email protected]
Sabina Aleixo, Principal Investigator
Not yet recruiting
Estado de Bahia
Hospital Samur, Vitória da Conquista, Estado de Bahia, 45.023-145, Brazil
Reinan Ferreira Jr., Contact, (77) 2102-8399, [email protected]
Augusto Madureira, Principal Investigator
Not yet recruiting
Federal District
Hospital de Base do Distrito Federal, Brasília, Federal District, 70.335-900, Brazil
Laryssa Silva, Contact, (61) 3550-8837, [email protected]
Luiza Weis, Principal Investigator
Not yet recruiting
Minas Gerais
Hospital do Câncer de Muriaé, Muriaé, Minas Gerais, 36.888-233, Brazil
Sergio Silva, Contact, (22) 99928-5576, [email protected]
Paula Gonçalves, Principal Investigator
Recruiting
Paraná
Centro de Oncologia de Cascavel, CEONC, Cascavel, Paraná, 85.803-760, Brazil
Rosangela Francener, Contact, (45) 99915-9622, [email protected]
Jordana Resende, Principal Investigator
Not yet recruiting
União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN, Cascavel, Paraná, 85.810-031, Brazil
Taciane Leal, Contact, (45) 2101-7000, [email protected]
Aline Gongora, Principal Investigator
Not yet recruiting
Centro Integrado de Oncologia de Curitiba, CIONC, Curitiba, Paraná, 80810-050, Brazil
Karina Vianna, Contact, (41) 3024-2421, [email protected]
Karina Vianna, Principal Investigator
Not yet recruiting
Rio de Janeiro
Instituto Nacional do Câncer, INCA, Rio de Janeiro, Rio de Janeiro, 20.220-410, Brazil
Andreia Melo, Contact, (21) 3207-1000
Flavia Alves, Contact, [email protected]
Recruiting
Rio Grande do Norte
Liga Norte Riograndense Contra o Câncer, Natal, Rio Grande do Norte, 59.062-000, Brazil
Kleyton Medeiros, Contact, (84) 99902-6430, [email protected]
Sulene Oliveira, Principal Investigator
Not yet recruiting
Rio Grande do Sul
Hospital Tacchini, Bento Gonçalves, Rio Grande do Sul, 95.700-084, Brazil
Brenda Santos, Contact, (54) 3455-4333, [email protected]
Alessandra Kaercher, Principal Investigator
Not yet recruiting
Hospital Geral de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, 95.070-561, Brazil
Ramone Bertussi, Contact, (54) 3218-7328, [email protected]
Janaina Brollo, Principal Investigator
Not yet recruiting
Hospital Bruno Born, Lajeado, Rio Grande do Sul, 95.900-010, Brazil
Rafael Seewald, Contact, (51) 37147558, [email protected]
Rafael Seewald, Principal Investigator
Not yet recruiting
Centro Gaúcho Integrado Hospital Mãe de Deus, Porto Alegre, Rio Grande do Sul, 90.850- 170, Brazil
Luis Castro, Contact, (51) 3307-2943, [email protected]
Christina Kussler, Principal Investigator
Not yet recruiting
Roraima
Centro Oncologico de Roraima, CECOR, Boa Vista, Roraima, 69.304-015, Brazil
Luana Vasconcelos, Contact, (95) 99118-2722, [email protected]
Allex Fonseca, Principal Investigator
Not yet recruiting
Santa Catarina
Catarina Pesquisa Clínica, Itajaí, Santa Catarina, 88.301-220, Brazil
Julia Bizatto, Contact, (47) 98432-0028, [email protected]
Giuliano Borges, Principal Investigator
Not yet recruiting
Hospital Unimed, Joinville, Santa Catarina, 89.204-061, Brazil
Ruthy Fernandes, Contact, (47)3441-4048, [email protected]
Andrea Santin, Principal Investigator
Recruiting
São Paulo
Centro de Atenção Integral a Saúde da Mulher, CAISM, Campinas, São Paulo, 13.083-881, Brazil
Regina Barros, Contact, (19) 3521-9476, [email protected]
Diama Vale, Principal Investigator
Not yet recruiting
Hospital do Amor, Jales, São Paulo, 15.706-396, Brazil
Joyce Almeida, Contact, (17) 3624-3900, [email protected]
Túlio Furquim, Principal Investigator
Not yet recruiting
Hospital da Mulher - SECONCI, São Paulo, São Paulo, 01.206-001, Brazil
Jackeline Garcia, Contact, (11) 99745-3996, [email protected]
Marcela Bonalumi, Principal Investigator
Recruiting
Hospital do Coração - Research Institute, São Paulo, São Paulo, 04.005-000, Brazil
Michelle S Almeida, PhD, Contact, (11) 999112805, [email protected]
Michelle S Almeida, PhD, Principal Investigator
Recruiting
Instituto Brasileiro de Combate ao Câncer, IBCC São Camilo, São Paulo, São Paulo, 04.015-070, Brazil
Alayne Yamada, Contact, (11) 4450-0347, [email protected]
Renata Meneguetti, Principal Investigator
Not yet recruiting
Hospital São Paulo, Unifesp, São Paulo, São Paulo, 04.024-002, Brazil
Vinicius Agibert, Contact, [email protected]
Hakaru Tadokoro, Principal Investigator
Vinicius Agibert, Sub-Investigator
Not yet recruiting
Hospital Santa Marcelina, São Paulo, São Paulo, 08.270-120, Brazil
Camila Guedes, Contact, (11) 2217-3766, [email protected]
Thais Almeida, Principal Investigator
Recruiting
Centro de Estudos e Pesquisa de Hematologia, CEPHO, São Paulo, São Paulo, 09.060-650, Brazil
Emanuelle Greque, Contact, (11) 97402-9832, [email protected]
Patricia Santi, Principal Investigator
Not yet recruiting
Instituo de Câncer Brasil, ICB, Taubaté, São Paulo, 12.030-200, Brazil
Bruna Campitelli, Contact, (12) 99212-7022, [email protected]
Luis Zucca, Principal Investigator
Not yet recruiting