Outcomes of Image-guided High-dose-rate Uterovaginal Brachytherapy With Single Implantation

NCT07213427 | Not Yet Recruiting

• 1 other identifier: APHP251146
• Study Type: observational
• Target: 363
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background and Rationale: Locally advanced cervical cancer remains a major public health concern worldwide and in France. Standard-of-care management involves concurrent chemoradiotherapy followed by brachytherapy, which is critical for local tumour control and survival. Conventional high-dose-rate (HDR) brachytherapy protocols often require multiple implantations under anaesthesia, entailing increased logistical demands, operating room use, and patient discomfort. The UNICURE-HD study investigates a simplified brachytherapy approach - a single intraoperative implantation delivering all planned fractions - combined with image guidance (MRI and/or CT) and 3D dosimetry, in order to assess whether it can maintain oncological outcomes while reducing treatment complexity and resource consumption. Objectives: Primary objective: To evaluate local control at 3 and 5 years after completion of chemoradiotherapy and image-guided HDR uterovaginal brachytherapy with single implantation. Secondary objectives: To assess pelvic nodal control, para-aortic nodal control, distant control, progression-free survival, overall survival, and acute/late severe toxicities (CTCAE v5.0 ≥ grade 3). Prognostic factors will be analysed, and exploratory predictive models will be developed. Study Design: This is a retrospective, observational, multicentre study involving six French cancer centres (Pitié-Salpêtrière, Saint-Louis, Tenon, Institut de Cancérologie de Lorraine, Centre Oscar Lambret, CHU de La Réunion). Eligible patients are women ≥18 years, diagnosed with FIGO 2018 stage IB3-IV cervical cancer, treated between January 2014 and June 2024 with concurrent chemoradiotherapy followed by image-guided HDR uterovaginal brachytherapy using a single implantation. Methods: Data will be extracted from medical records (electronic or paper), pseudonymised locally, and entered into a secure AP-HP-hosted database compliant with GDPR and the MR004 framework. Variables collected include demographics, tumour characteristics, EBRT details, brachytherapy technique (endocavitary vs hybrid/interstitial), dosimetric parameters (EQD2 for HR-CTV, IR-CTV, OARs), and outcomes. Imaging protocols, applicator types, and treatment times will also be recorded. Statistical analysis will use descriptive statistics, Kaplan-Meier survival estimation, log-rank tests, and multivariable Cox regression. Predictive models (LASSO, random forests) will be explored. Analyses will be conducted in R software. Sample Size: Approximately 400 patients are expected, representing all eligible cases treated over the 10-year period in the participating centres. Ethics and Regulatory Compliance: The study follows GDPR and French data protection regulations (MR004). Ethics opinion has been requested from the Sorbonne Université Ethics Committee. Each centre will retain the correspondence table linking identifiers to pseudonyms locally; no directly identifying data will be shared. Potential Impact: If the single-implantation HDR brachytherapy strategy achieves equivalent tumour control and toxicity profiles compared to multi-implant protocols, it could streamline cervical cancer management, reduce anaesthetic risk, improve patient comfort, and optimise resource use in high-volume oncology departments. This could have significant implications for accessibility and cost-effectiveness of cervical cancer care, particularly in settings with limited resources.

Conditions

LOCALLY ADVANCED CERVICAL CANCERS

Keywords

Brachytherapy; gynaecologic; oncology; single-insertion; dosimetry

Outcome Measures

Primary Outcomes (1)

• Local control, overall survival

  Local control (LC) was defined as the absence of persistent tumor or relapse in the cervix, uterus, or paracervical region. Overall survival (OS) was measured from the start of treatment to death from any cause.

  January 1, 2014 - June 15, 2024

Secondary Outcomes (2)

• Failure-free survival

  January 1, 2014 - June 15, 2024

• overall survival

  January 1, 2014 - June 15, 2024

Interventions

data collection OTHER

Collection of relevant medical data (clinical data, imaging, treatment, follow-up, toxicities), performed locally by investigators or authorized members of the medical team.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Locally advanced cervical cancer (FIGO 2018: IB3-IV) treated with concurrent chemoradiotherapy followed by HDR uterovaginal brachytherapy

You may qualify if:

• Women aged 18 years or older
• Diagnosis of locally advanced cervical cancer (squamous cell carcinoma, adenocarcinoma, or other)
• FIGO stage IB3-IV
• Treatment with chemoradiotherapy followed by uterovaginal brachytherapy with implantation in the operating room
• Informed and not opposed to the collection of her data for research purposes

You may not qualify if:

• Lack of information regarding follow-up
• Patient under legal protection measures -

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Neoplasms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: October 8, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
• Access Criteria: Researchers who provide a methodologically sound proposal.