Locally Advanced Cervical CancerCERVITALNCT07743918
Vitamin D Status and Clinical Outcomes in Locally Advanced Cervical Cancer
An observational study of Locally Advanced Cervical Cancer and Vitamin D Concentration, run by University of Kragujevac at 1 site in Serbia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer, Vitamin D Concentration
- What is being tested?
- Pretreatment Vitamin D Assessment in Serum and Cervical Lavage Fluid
- How many people
- 100 participants
- Where
- 1 siteSerbia
- Study dates
- 1 Jan 2026to 1 Sep 2034
- How long will I take part?
- 7 Months
- Phase
- Observational
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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
- Planned treatment with definitive concurrent chemoradiotherapy.
- Signed informed consent.
- Ability to comply with study procedures and follow-up visits.
Who cannot join
- Age under 18 years.
- Pregnancy or lactation.
- Previous or synchronous diagnosis of another pelvic or abdominal malignancy.
- Previous chemotherapy.
- Previous radiotherapy.
- Previous treatment with immune checkpoint inhibitors.
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- Current or recent vitamin D supplementation.
- Interrupted oncological treatment.
- Failure to attend scheduled follow-up visits.
- Incomplete medical documentation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marija Živković Radojević, MD, PhD, Radiation Oncologist contact
Serbia1 site, 1 recruiting
- Recruiting
University Clinical Center Kragujevac
Kragujevac, Šumadija, 34000
Marija Živković Radojević, MD, PhD, Radiation Oncologist, +381658384450, makizivkovicmarija@gmail.com
About this study
Official title: Pretreatment Vitamin D Status and Clinical Outcomes in Patients With Locally Advanced Cervical Cancer Undergoing Definitive Chemoradiotherapy
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.
Read the detailed description
Definitive concurrent chemoradiotherapy is the standard treatment for locally advanced cervical cancer. Although it achieves high response rates, some patients do not attain a complete therapeutic response, potentially because of chemoradioresistance. Radiotherapy also exerts immunomodulatory effects within the tumor microenvironment, which may be particularly relevant in cervical cancer because of its association with persistent human papillomavirus infection. Identifying biomarkers associated with treatment response and toxicity could therefore support more individualized treatment strategies.
Vitamin D regulates cellular proliferation and differentiation, immune responses, and inflammatory processes. Hypovitaminosis D and reduced vitamin D receptor expression have been associated with cervical cancer and other malignancies. However, the predictive value of pretreatment vitamin D status in patients undergoing modern definitive chemoradiotherapy remains insufficiently established.
Pretreatment vitamin D concentrations will be measured in serum and cervical lavage fluid. All participants will receive standard definitive treatment comprising external beam radiotherapy, brachytherapy, and concurrent weekly cisplatin-based chemotherapy. Acute treatment-related toxicity will be assessed throughout chemoradiotherapy, and the definitive therapeutic response will be evaluated by pelvic magnetic resonance imaging five months after treatment completion.
Pretreatment serum and cervical lavage vitamin D concentrations will be analyzed in relation to therapeutic response, acute treatment-related toxicity, and relevant clinical, morphological, treatment-related, and sociodemographic parameters. The study will also evaluate the correlation between systemic and local vitamin D concentrations and explore potential cut-off values for predicting complete therapeutic response and clinically significant acute toxicity. Participants with low pretreatment vitamin D concentrations will not receive supplementation as part of the study protocol.
- Being tested
- Pretreatment Vitamin D Assessment in Serum and Cervical Lavage Fluid
- Keywords
- Locally advanced cervical cancer;, vitamin D;, hypovitaminosis D;, serum vitamin D;, cervical lavage;, chemoradiotherapy;, radiotherapy;, cisplatin;, brachytherapy;, treatment response;, radiation toxicity;, RECIST 1.1;, CTCAE;, chemoradiosensitivity;, chemoradioresistency
- Medical subject headings
- Vitamin D Deficiency, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pretreatment Vitamin D Assessment in Serum and Cervical Lavage FluidDiagnostic test
Vitamin 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.
| Study group | Role | What they receive |
|---|---|---|
| Locally Advanced Cervical Cancer Cohort | Patients with histopathologically confirmed locally advanced cervical cancer, FIGO 2018 stage IIB-IVA, treated with definitive concurrent chemoradiotherapy. Pretreatment vitamin D concentrations will be measured in serum and cervical lavage fluid before treatment initiation, and patients will be followed for treatment response and acute radiation toxicity. Receives: Diagnostic Test: Pretreatment Vitamin D Assessment in Serum and Cervical Lavage Fluid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Five months after the last radiotherapy fraction.
Secondary outcomes (7)
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.
Measured: First radiotherapy fraction until 90th day (acute toxicity).
Severity of acute radiation toxicity
The maximum grade of acute radiation toxicity observed during chemoradiotherapy, assessed according to CTCAE v.6 criteria.
Measured: First radiotherapy fraction until 90th day.
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.
Measured: Baseline before treatment initiation and five months after the last radiotherapy fraction.
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.
Measured: Baseline before treatment initiation and five months after the last radiotherapy fraction.
Association between pretreatment vitamin D concentration and acute radiation toxicity
Association between pretreatment vitamin D concentrations in serum and cervical lavage fluid and the occurrence of clinically significant acute radiation toxicity, defined as CTCAE v.6 grade II or higher.
Measured: Baseline before treatment initiation and 90th day.
Correlation Between Serum and Cervical Lavage Vitamin D Concentrations
Correlation between pretreatment vitamin D concentrations measured in serum and cervical lavage fluid.
Measured: Baseline before initiation of chemoradiotherapy.
Optimal pretreatment vitamin D cut-off value for prediction of treatment response and toxicity
Receiver operating characteristic curve analysis will be used to determine the optimal pretreatment vitamin D cut-off value for prediction of complete therapeutic response and clinically significant acute radiation toxicity.
Measured: Five months after the last radiotherapy fraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Jan 2026
- Primary completion10 Jan 2028 (estimated)
- Study completion1 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- University of Kragujevac
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marija Zivkovic Radojevic, University of Kragujevac
- Investigators
- Marija Živković Radojević, MD, PhD, Radiation Oncologist, Principal investigator, Faculty of Medical Sciences, University of Kragujevac, Serbia, University Clinical Centre Kragujevac, Center for radiation oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743918
- Sponsor's protocol ID
- CERVITAL-2025
- Acronym
- CERVITAL
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes sensitive clinical, imaging, radiotherapy, toxicity, and biomarker data from patients with locally advanced cervical cancer. Data sharing is not planned in the current protocol and would require additional ethical approval, appropriate anonymization procedures, and a formal data sharing agreement.