Ultraaccelerated high-dose-rate intrauterine brachytherapy for locally advanced cervical cancer

EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity

This project tests a faster, higher-dose internal radiation (brachytherapy) after chemoradiation to see if bowel, bladder, vaginal, and sexual side effects are acceptable for people with locally advanced cervical cancer.

Quick facts

• Study type: Observational
• Enrollment: 129 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Rome)
• Trial ID: NCT06398938 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-center observational study enrolling patients with FIGO IB2–IVA locally advanced cervical cancer who receive standard radiochemotherapy followed by an accelerated schedule of high-dose-rate intrauterine interventional radiotherapy (brachytherapy). The protocol records acute and long-term gastrointestinal and urinary toxicities as well as effects on vaginal tissues and sexual activity. All participants undergo baseline and follow-up pelvic MRI and standardized toxicity and sexual-function assessments. The primary focus is on the frequency and severity of severe acute and late toxicities associated with the accelerated brachytherapy schedule.

Who should consider this trial

Good fit: Adults (≥18 years) with histologically confirmed squamous carcinoma or adenocarcinoma of the cervix, ECOG 0–2, FIGO stage IB2–IVA, no distant metastases outside pelvic nodes, able to undergo pelvic MRI and willing to give informed consent are ideal candidates.

Not a fit: Patients with poor performance status (>2), prior pelvic radiation, recent other cancers, distant metastases beyond pelvic lymph nodes, or medical contraindications to radiotherapy or chemoradiotherapy are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, the approach could shorten the overall local treatment time while maintaining acceptable side effects, improving convenience and potentially clinical outcomes.

How similar studies have performed: Accelerated brachytherapy approaches have been reported in the literature with mixed toxicity and efficacy results, so this protocol builds on prior work but is not a widely established standard.

Eligibility criteria

Inclusion Criteria:

* Age ≥18 years
* ECOG 0-2
* Histological diagnosis of squamous carcinoma and/or adenocarcinoma of the uterine cervix
* FIGO IB2 Stadium - IVA (staging 20018)
* No contraindications to performing MRI of the pelvis
* Informed consent

Exclusion Criteria:

* Age \<18 years
* PS \>2
* Previous cancer in the last 10 years
* Previous radiation treatment in the region of interest
* Presence of pathologies that contraindicate radiotherapy treatment (genetic syndromes of hyper-radiosensitivity, ulcerative colitis, diverticulitis in the acute phase, severe diverticulosis, chronic pelvic inflammation)
* Presence of internal diseases that contraindicate chemotherapy or radio-chemotherapy treatment (severe liver disease, heart disease, renal failure, etc.)
* Presence of distant metastases in sites other than the pelvic lymph nodes
* Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study

Where this trial is running

Rome

• Fondazione Policlinico Universitario A. Gemelli, IRCCS — Rome, Italy (Recruiting)

Study contacts

• Principal investigator: Valentina Lancellotta — Fondazione Universiataria Policlinico A Gemelli IRCCS
• Study coordinator: Valentina Lancellotta

Conditions Locally Advanced Cervical Carcinoma; cervical carcinoma; interventional radiotherapy; acute and late toxicities; radiochemotherapy