NCT05764044

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
365

participants targeted

Target at P50-P75 for phase_3

Timeline
8mo left

Started Mar 2024

Typical duration for phase_3

Geographic Reach
1 country

26 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress77%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

March 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 10, 2023

Completed
1 year until next milestone

Study Start

First participant enrolled

March 27, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 30, 2024

Status Verified

July 1, 2024

Enrollment Period

2.8 years

First QC Date

March 1, 2023

Last Update Submit

July 28, 2024

Conditions

Cervical CancerCervix CancerCervix Neoplasm

Keywords

Human papillomavirusHPVCervical cancerCirculating free DNAAdjuvant chemotherapy

Outcome Measures

Primary Outcomes (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.

    120 days

Secondary Outcomes (4)

  • Overall survival

    120 days

  • Overall response rate

    120 days

  • Quality of life measures (EORTC QLQ-C30 and QLC-CX24)

    21 to 120 days

  • Toxicity according to the Common Terminology Criteria for Adverse Events v.5.0

    7 to 120 days

Study Arms (2)

Control Arm (Standard of Care)

OTHER

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.

Other: Follow-up

Experimental Arm

EXPERIMENTAL

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.

Drug: cisplatin, gemcitabineOther: Follow-up

Interventions

cisplatin, gemcitabineDRUG

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

Experimental Arm
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.

Control Arm (Standard of Care)Experimental Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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 chemoradiotherapy,
  • 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).

You may not qualify 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Centro Integrado de Pesquisa da Amazônia, CINPAM

Manaus, Amazonas, 69.020-030, Brazil

RECRUITING

Hospital Evangélico de Cachoeiro de Itapemirim

Cachoeiro de Itapemirim, Espírito Santo, 29.308-065, Brazil

NOT YET RECRUITING

Hospital Samur

Vitória da Conquista, Estado de Bahia, 45.023-145, Brazil

NOT YET RECRUITING

Hospital de Base do Distrito Federal

Brasília, Federal District, 70.335-900, Brazil

NOT YET RECRUITING

Hospital do Câncer de Muriaé

Muriaé, Minas Gerais, 36.888-233, Brazil

RECRUITING

Centro de Oncologia de Cascavel, CEONC

Cascavel, Paraná, 85.803-760, Brazil

NOT YET RECRUITING

União Oeste Paranaense de Estudos e Combate ao Câncer, UOPECCAN

Cascavel, Paraná, 85.810-031, Brazil

NOT YET RECRUITING

Centro Integrado de Oncologia de Curitiba, CIONC

Curitiba, Paraná, 80810-050, Brazil

NOT YET RECRUITING

Instituto Nacional do Câncer, INCA

Rio de Janeiro, Rio de Janeiro, 20.220-410, Brazil

RECRUITING

Liga Norte Riograndense Contra o Câncer

Natal, Rio Grande do Norte, 59.062-000, Brazil

NOT YET RECRUITING

Hospital Tacchini

Bento Gonçalves, Rio Grande do Sul, 95.700-084, Brazil

NOT YET RECRUITING

Hospital Geral de Caxias do Sul

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

NOT YET RECRUITING

Hospital Bruno Born

Lajeado, Rio Grande do Sul, 95.900-010, Brazil

NOT YET RECRUITING

Centro Gaúcho Integrado Hospital Mãe de Deus

Porto Alegre, Rio Grande do Sul, 90.850- 170, Brazil

NOT YET RECRUITING

Centro Oncologico de Roraima, CECOR

Boa Vista, Roraima, 69.304-015, Brazil

NOT YET RECRUITING

Catarina Pesquisa Clínica

Itajaí, Santa Catarina, 88.301-220, Brazil

NOT YET RECRUITING

Hospital Unimed

Joinville, Santa Catarina, 89.204-061, Brazil

RECRUITING

Centro de Atenção Integral a Saúde da Mulher, CAISM

Campinas, São Paulo, 13.083-881, Brazil

NOT YET RECRUITING

Hospital do Amor

Jales, São Paulo, 15.706-396, Brazil

NOT YET RECRUITING

Hospital da Mulher - SECONCI

São Paulo, São Paulo, 01.206-001, Brazil

RECRUITING

Hospital do Coração - Research Institute

São Paulo, São Paulo, 04.005-000, Brazil

RECRUITING

Instituto Brasileiro de Combate ao Câncer, IBCC São Camilo

São Paulo, São Paulo, 04.015-070, Brazil

NOT YET RECRUITING

Hospital São Paulo, Unifesp

São Paulo, São Paulo, 04.024-002, Brazil

NOT YET RECRUITING

Hospital Santa Marcelina

São Paulo, São Paulo, 08.270-120, Brazil

RECRUITING

Centro de Estudos e Pesquisa de Hematologia, CEPHO

São Paulo, São Paulo, 09.060-650, Brazil

NOT YET RECRUITING

Instituo de Câncer Brasil, ICB

Taubaté, São Paulo, 12.030-200, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

CisplatinGemcitabine

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-Ring

Central Study Contacts

Michelle S Almeida, PhD

CONTACT

11 999112805malmeida@hcor.com.br

Rachel H Machado, MCS

CONTACT

11 30536611rhelena@hcor.com.br

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2023

First Posted

March 10, 2023

Study Start

March 27, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 30, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will share

Data could be shared after reasonable request of the principal investigator.

Shared Documents
STUDY PROTOCOL
Time Frame
After study completion.

Locations

BR(26)