Skip to content

A Radiomic MRI Predictive Model for Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer

Developing a Radiomic MRI Model Predictive of Response to Concomitant Chemoradiotherapy in Locally Advanced Cervical Cancer. A Prognostic, Retrospective, Open-label, Multicenter, Descriptive and Analytical Clinical Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07305727
Acronym
EPICOL-R
Enrollment
120
Registered
2025-12-26
Start date
2026-01-01
Completion date
2026-12-31
Last updated
2026-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer by FIGO Stage 2018, Uterine Cervical Neoplasms

Keywords

cancer, cervix, survival modeling, radiomic models

Brief summary

Cervical cancer is the fourth most common cancer in women worldwide, with approximately 604,000 new cases in 2020.Treatment for locally advanced cervical cancer is based on a combination of radiotherapy and chemotherapy. The response to concomitant chemoradiotherapy vary from one woman to another. Predicting the response to these treatments would allow early consideration of alternative therapies for patients identified as less responsive to standard treatments. A 5-year recurrence-free survival is approximately 79% for stages IB and IIA and 59% for stages III and IVA, with approximately 36% of local failures despite chemoradiotherapy. In a few studies,the radiomic MRI approach in locally advanced cervical cancers has shown to be prognostic for locoregional recurrence or survival but these models still need to be explored and validated.The EPICOL cohort, a clinical-biological cohort of 136 patients treated with chemoradiotherapy for locally advanced cervical cancer at the Montpellier Cancer Institute or Nîmes University Hospital, will be used to develop a predictive model of response to chemoradiotherapy based on radiomic data from pelvic MRIs before and after treatment.

Detailed description

Cervical cancer is an invasive cancer that develops from the squamous epithelium of the cervix. Worldwide, cervical cancer is the fourth most common cancer in women, with approximately 604,000 new cases in 2020.Treatment for locally advanced cervical cancer (FIGO stage IB3 to IVA) is based on a combination of radiotherapy and chemotherapy (cisplatin 40 mg/m2 x5 or 6 or carboplatin area under the curve 2 if cisplatin is contraindicated). Responses to concomitant chemoradiotherapy remain highly heterogeneous from one woman to another, and predicting the response to these treatments would allow early consideration of alternative therapies for patients identified as less responsive to standard treatments. Indeed, 5-year recurrence-free survival is approximately 79% for stages IB and IIA and 59% for stages III and IVA, with approximately 36% of local failures despite chemoradiotherapy. The radiomic MRI approach in locally advanced cervical cancers has shown in a few studies to be prognostic for locoregional recurrence or survival. However, these models still need to be explored and validated before they can be implemented in routine clinical practice. The EPICOL cohort is a clinical-biological cohort of 136 patients treated with chemoradiotherapy for locally advanced cervical cancer at the Montpellier Cancer Institute or Nîmes University Hospital. The aim is to develop a predictive model of response to chemoradiotherapy based on radiomic data from pelvic MRIs before and after treatment from the EPICOL cohort.

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients treated with exclusive radio-chemotherapy for locally advanced cervical cancer (stage Ib-IVb according to the FIGO classification). * Patients with a minimum of 2 years of post-treatment follow-up. * Patients for whom the initial biopsy specimen (prior to treatment) is available. * Patients who have not expressed their opposition to participating in the study. * Patients who are affiliated with or beneficiaries of a health insurance plan.

Exclusion criteria

* Patients under judicial protection, guardianship, or curatorship

Design outcomes

Primary

MeasureTime frameDescription
Prognostic role of a magnetic resonance imaging radiomic model on progression-free survival in patients treated for locally advanced cervical cancer.Month 24Time from diagnosis to death from any cause or progression (according to RECIST v1.1 criteria) at 24 months of follow-up.

Secondary

MeasureTime frameDescription
Prognostic role of an magnetic resonance imaging radiomic model on overall survival in patients treated for locally advanced cervical cancer.Month 24Time between treatment initiation and death from any cause at 24 months of follow-up.
Correlation between the radiomic magnetic imaging radiomic model and Programmed cell Death protein 1 (PD-L1) expression.Month 24Collection of Programmed cell Death protein 1 (PD-L1) expression levels from biopsies from the EPICOL cohort.
Correlation between the radiomic magnetic resonance imaging model and tumor-infiltrating lymphocytes (TILs).Month 24Collection of tumor-infiltrating lymphocyte (TIL) expression levels in biopsies from the EPICOL cohort.

Countries

France

Contacts

Primary ContactFrédéric FITENI, Professor
frederic.fiteni@chu-nimes.fr+334.34.03.46.69
Backup ContactAnissa MEGZARI
drc@chu-nimes.fr0466684236

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026