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

ConditionsCervical CancerCervix CancerCervix Neoplasm
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorHospital do Coracao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Previous cervical cancer or other malignancies,

Pregnant women,

Inability to perform concurrent cisplatin based-chemoradiotherapy.

Tumors containing different HPV genotypes

Trial design

Design model

Parallel

Treatments tested in this trial

  • cisplatin, gemcitabine

    Drug

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

  • Follow-up

    Other intervention

    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.

Treatment groups

365 Participants
are divided into 2 treatment groups
Group A: Control Arm (Standard of Care)Other 1 intervention
Group B: Experimental ArmExperimental treatment 2 interventions

Trial outcomes

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.

Time frame
120 days

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
7 to 120 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital do Coracao

Lead sponsor

University of Sao Paulo

Collaborator

Source ClinicalTrials.gov
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