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Cervical CancerPhase 3AddChemoNCT05764044

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

A Phase 3 study testing cisplatin, gemcitabine and Follow-up in people with Cervical Cancer and Cervix Cancer, run by Hospital do Coracao at 26 sites in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer, Cervix Cancer, Cervix Neoplasm
What is being tested?
cisplatin, gemcitabine and Follow-up
Could I receive a placebo?
No, everyone receives an active treatment
How many people
365 participants
Where
26 sitesBrazil
Study dates
27 Mar 2024to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

26 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Michelle S Almeida, PhD contact

11 999112805

malmeida@hcor.com.br

Rachel H Machado, MCS contact

11 30536611 ext. 8220

rhelena@hcor.com.br

26 sites in 1 country

Brazil26 sites, 26 recruiting

  • Hospital Tacchini

    Bento Gonçalves, Rio Grande do Sul, 95.700-084

    Brenda Santos, (54) 3455-4333, brenda.santos@tacchini.com.br

    Alessandra Kaercher

    Not yet recruiting

  • Centro Oncologico de Roraima, CECOR

    Boa Vista, Roraima, 69.304-015

    Luana Vasconcelos, (95) 99118-2722, luana.luana.silva53@hotmail.com

    Allex Fonseca

    Not yet recruiting

  • Hospital de Base do Distrito Federal

    Brasília, Federal District, 70.335-900

    Laryssa Silva, (61) 3550-8837, laryssa.silva@igesdf.org.br

    Luiza Weis

    Not yet recruiting

  • Hospital Evangélico de Cachoeiro de Itapemirim

    Cachoeiro de Itapemirim, Espírito Santo, 29.308-065

    Narelle Parmanhani, (28) 3522-5095, narelle@iosc.com.br

    Sabina Aleixo

    Not yet recruiting

  • Centro de Atenção Integral a Saúde da Mulher, CAISM

    Campinas, São Paulo, 13.083-881

    Regina Barros, (19) 3521-9476, pesquisaonco@caism.unicamp.br

    Diama Vale

    Not yet recruiting

  • Centro de Oncologia de Cascavel, CEONC

    Cascavel, Paraná, 85.803-760

    Rosangela Francener, (45) 99915-9622, enfcentrodepesquisa@ceonc.com.br

    Jordana Resende

    Not yet recruiting

  • União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN

    Cascavel, Paraná, 85.810-031

    Taciane Leal, (45) 2101-7000, taciane.leal@uopeccan.org.br

    Aline Gongora

    Not yet recruiting

  • Hospital Geral de Caxias do Sul

    Caxias do Sul, Rio Grande do Sul, 95.070-561

    Ramone Bertussi, (54) 3218-7328, rabertus@ucs.br

    Janaina Brollo

    Not yet recruiting

  • Centro Integrado de Oncologia de Curitiba, CIONC

    Curitiba, Paraná, 80810-050

    Karina Vianna, (41) 3024-2421, pesquisaclinica@cionc.com.br

    Karina Vianna

    Not yet recruiting

  • Catarina Pesquisa Clínica

    Itajaí, Santa Catarina, 88.301-220

    Julia Bizatto, (47) 98432-0028, julia@catarinapesquisa.com.br

    Giuliano Borges

    Not yet recruiting

  • Hospital do Amor

    Jales, São Paulo, 15.706-396

    Joyce Almeida, (17) 3624-3900, joyce.ramos@hospitaldeamor.com.br

    Túlio Furquim

    Not yet recruiting

  • Hospital Unimed

    Joinville, Santa Catarina, 89.204-061

    Ruthy Fernandes, (47)3441-4048, ruthyf@joinville.unimedsc.com.br

    Andrea Santin

    Recruiting

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95.900-010

    Rafael Seewald, (51) 37147558, pesquisaclinica@hbb.com.br

    Rafael Seewald

    Not yet recruiting

  • Centro Integrado de Pesquisa da Amazônia, CINPAM

    Manaus, Amazonas, 69.020-030

    Patricia Serra, (92) 9130-8097, coordenacao@cinpam.com.br

    Gilmara Resende

    Recruiting

  • Hospital do Câncer de Muriaé

    Muriaé, Minas Gerais, 36.888-233

    Sergio Silva, (22) 99928-5576, sergio.silva@fcv.org.br

    Paula Gonçalves

    Recruiting

  • Liga Norte Riograndense Contra o Câncer

    Natal, Rio Grande do Norte, 59.062-000

    Kleyton Medeiros, (84) 99902-6430, kleyton.medeiros@liga.org.br

    Sulene Oliveira

    Not yet recruiting

  • Centro Gaúcho Integrado Hospital Mãe de Deus

    Porto Alegre, Rio Grande do Sul, 90.850- 170

    Luis Castro, (51) 3307-2943, luiscastro.pesquisa@gmail.com

    Christina Kussler

    Not yet recruiting

  • Instituto Nacional do Câncer, INCA

    Rio de Janeiro, Rio de Janeiro, 20.220-410

    Andreia Melo, (21) 3207-1000

    Flavia Alves, falves@inca.gov.br

    Recruiting

  • Hospital da Mulher - SECONCI

    São Paulo, São Paulo, 01.206-001

    Jackeline Garcia, (11) 99745-3996, gabriela.dona@unifesp.br

    Marcela Bonalumi

    Recruiting

  • Hospital do Coração - Research Institute

    São Paulo, São Paulo, 04.005-000

    Michelle S Almeida, PhD, (11) 999112805, malmeida@hcor.com.br

    Michelle S Almeida, PhD

    Recruiting

  • Instituto Brasileiro de Combate ao Câncer, IBCC São Camilo

    São Paulo, São Paulo, 04.015-070

    Alayne Yamada, (11) 4450-0347, alayne.yamada@hospitalsaocamilosp.org.br

    Renata Meneguetti

    Not yet recruiting

  • Hospital São Paulo, Unifesp

    São Paulo, São Paulo, 04.024-002

    Vinicius Agibert, v.agibert09@gmail.com

    Hakaru Tadokoro

    Not yet recruiting

  • Hospital Santa Marcelina

    São Paulo, São Paulo, 08.270-120

    Camila Guedes, (11) 2217-3766, camilacpc@santamarcelina.org

    Thais Almeida

    Recruiting

  • Centro de Estudos e Pesquisa de Hematologia, CEPHO

    São Paulo, São Paulo, 09.060-650

    Emanuelle Greque, (11) 97402-9832, emanuelle.greque@cepho.org.br

    Patricia Santi

    Not yet recruiting

  • Instituo de Câncer Brasil, ICB

    Taubaté, São Paulo, 12.030-200

    Bruna Campitelli, (12) 99212-7022, brunagiovaneti@institutodocancerbrasil.com.br

    Luis Zucca

    Not yet recruiting

  • Hospital Samur

    Vitória da Conquista, Estado de Bahia, 45.023-145

    Reinan Ferreira Jr., (77) 2102-8399, pesquisa@hospitalsamur.com.br

    Augusto Madureira

    Not yet recruiting

Other trials in Brazil

About this study

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

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.

Read the 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 randomized list will be generated by using a suitable software, using variable size blocks (2 or 4), with stratification for site and staging. The confidentiality of the randomization list will be maintained through an automated, centralized, Internet-based randomization system, available 24 hours a day (RedCap). Selected patients must receive standard treatment based on concomitant chemoradiotherapy regime, with dose of radiation of 40-50 greys (Gy) (considering additional boost of 10-15 Gy in lymph nodes, radiologically or surgically, compromised) and brachytherapy of 30-40 Gy and cisplatin 40mg/m2 weekly. After four weeks of the end of treatment, a qualitative and quantitative research of cfHPV-DNA in plasma of patients will be conducted. Those with a negative qualitative research result will leave the study. Patients who have positive research for plasma 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68, 69, 73, 82 cfHPV-DNA at the end of chemoradiotherapy treatment will be randomized to receive two additional cycles of adjuvant chemotherapy or observation. In those cases in which the duration of radiochemotherapy treatment exceeds 84 days, patients must undergo imaging examination (chest, abdomen and pelvis CT) in order to exclude pre-randomization metastatic disease. 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.

Being tested
cisplatin, gemcitabine, Follow-up
Keywords
Human papillomavirus, HPV, Cervical cancer, Circulating free DNA, Adjuvant chemotherapy
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cisplatin, gemcitabineDrug

    Two additional cycles of cisplatin-based adjuvant chemotherapy 50mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 at every 21 days.

  • Follow-upOther

    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.

Study groups in NCT05764044
Study groupRoleWhat they receive
Control Arm (Standard of Care)OtherPatients 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.
Receives: Other: Follow-up
Experimental ArmExperimentalReceive 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.
Receives: Drug: cisplatin, gemcitabine; Other: Follow-up

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 120 days

Secondary outcomes (4)

  1. 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.

    Measured: 120 days

  2. 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.

    Measured: 120 days

  3. 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.

    Measured: 21 to 120 days

  4. 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.

    Measured: 7 to 120 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start27 Mar 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model 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. Intervention arm will count on application of two additional cycles of cisplatin-based adjuvant chemotherapy 50mg/m2 D1 and gemcitabine 1000mg/m2 D1 and D8 at every 21 days. Randomization will be allocated 1:1. Participants will be followed at every 4 months, in person or by phone. Primary endpoint is progression-free survival time.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
365 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05764044
Sponsor's protocol ID
AddChemo CC Trial
Acronym
AddChemo
Status last verified
Jul 2024
First submitted
1 Mar 2023
Last updated
30 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data could be shared after reasonable request of the principal investigator.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing cisplatin, gemcitabine and Follow-up in people with Cervical Cancer and Cervix Cancer, run by Hospital do Coracao at 26 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michelle S Almeida, PhD (11 999112805, malmeida@hcor.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 120 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05764044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.

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