Vitamin D Status and Clinical Outcomes in Locally Advanced Cervical Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-80
SponsorUniversity of Kragujevac
About this trial
Background. Definitive chemoradiotherapy represents the standard therapeutic approach for the management of locally advanced cervical cancer. Vitamin D plays an important role in the regulation of cellular growth and differentiation, immune system function, and the modulation of inflammatory processes. Hypovitaminosis D may be associated with the development of cervical cancer, whereas its impact on the effects of oncological treatment remains insufficiently elucidated. The aim of this study is to investigate the predictive significance of vitamin D in patients with locally advanced cervical cancer treated with definitive chemoradiotherapy.
Methods. This study is designed as a clinical, observational, prospective cohort study. Patients with locally advanced cervical cancer undergoing definitive chemoradiotherapy at the Clinic for Radiation Oncology, University Clinical Center Kragujevac, will be enrolled. Vitamin D concentrations will be measured before the initiation of treatment in both serum and cervical lavage samples. Baseline vitamin D levels will be analyzed in relation to treatment outcome and the occurrence of acute radiation toxicity. In addition, vitamin D concentrations will be evaluated in the context of clinical and morphological parameters, therapeutic response, and treatment-related toxicity.
Expected Results. This study will enable an assessment of the actual significance of pretreatment vitamin D concentrations in serum and cervical lavage as a potential novel biomarker in relation to chemoradiosensitivity and/or chemoradioresistance of cervical cancer, as well as the response of organs at risk, in patients with locally advanced disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Female patients aged 18 to 80 years.
Histopathologically confirmed cervical cancer.
Locally advanced disease, FIGO 2018 stage IIB to IVA.
Eastern Cooperative Oncology Group performance status 0-1.
Disqualifiers
Age under 18 years.
Pregnancy or lactation.
Previous or synchronous diagnosis of another pelvic or abdominal malignancy.
Previous chemotherapy.
Trial population
The study population will include adult individuals who self-identify as female, aged 18 to 80 years, with histopathologically confirmed locally advanced cervical cancer, FIGO 2018 stage IIB-IVA, who are planned for definitive concurrent chemoradiotherapy at the Clinic for Radiation Oncology, University Clinical Center Kragujevac. All participants must provide written informed consent and be eligible for standard treatment consisting of external beam radiotherapy, high-dose-rate brachytherapy, and weekly cisplatin-based chemotherapy.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Pretreatment Vitamin D Assessment in Serum and Cervical Lavage Fluid
Diagnostic testVitamin D concentrations will be measured before the initiation of definitive chemoradiotherapy in serum and cervical lavage fluid using chemiluminescence, as the standard institutional laboratory method. Baseline vitamin D levels will be analyzed in relation to treatment response, acute radiation toxicity, and selected clinical, morphological, treatment-related, and socio-demographic parameters.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Locally Advanced Cervical Cancer Cohort1 intervention
Trial outcomes
Primary outcomes
1
Complete therapeutic response after definitive chemoradiotherapy
The proportion of patients achieving complete therapeutic response after definitive concurrent chemoradiotherapy. Treatment response will be assessed by pelvic magnetic resonance imaging and clinical examination, according to RECIST 1.1 criteria.
Time frame
Five months after the last radiotherapy fraction.Secondary outcomes
1
Clinically significant acute radiation toxicity
The proportion of patients developing clinically significant acute radiation toxicity during definitive chemoradiotherapy. Clinically significant toxicity will be defined as CTCAE v. 6 grade II or higher.
Time frame
First radiotherapy fraction until 90th day (acute toxicity).2
Severity of acute radiation toxicity
The maximum grade of acute radiation toxicity observed during chemoradiotherapy, assessed according to CTCAE v.6 criteria.
Time frame
First radiotherapy fraction until 90th day.3
Association between pretreatment serum vitamin D concentration and treatment response
Association between pretreatment serum vitamin D concentration and complete therapeutic response versus absence of complete therapeutic response after definitive chemoradiotherapy. Serum vitamin D concentration will be measured before treatment initiation using chemiluminescence as the standard institutional laboratory method.
Time frame
Baseline before treatment initiation and five months after the last radiotherapy fraction.4
Association between pretreatment cervical lavage vitamin D concentration and treatment response
Association between pretreatment vitamin D concentration in cervical lavage fluid and complete therapeutic response versus absence of complete therapeutic response after definitive chemoradiotherapy. Vitamin D concentration in cervical lavage fluid will be measured before treatment initiation using chemiluminescence as the standard institutional laboratory method.
Time frame
Baseline before treatment initiation and five months after the last radiotherapy fraction.Sponsors and contacts
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Source ClinicalTrials.gov