NCT06398938Recruiting
Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy
EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity
Source: ClinicalTrials.gov · Last updated 15 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the degree of acute and long-term intestinal, urinary and vaginal toxicity, and the impact on sexual activity of an accelerated fractionation of high dose rate interventional radiotherapy (IRT-HDR) in patients with locally advanced cervical cancer (IB2 - VA, N+/-).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 129 (estimated)
- First submitted
- 24 Apr 2024
- Start date
- 6 May 2024
- Primary completion date
- 30 May 2025
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Cervical cancer
- NCT number
- NCT06398938
What you commit to
- Study type: Observational
- Planned participants: 129
- From 6 May 2024 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous radiation treatment in the region of interest
Other illness
- Previous cancer in the last 10 years
- 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.)
- Any significant medical condition that in the opinion of the investigator may interfere with the patient's optimal participation in the study
Age
- Age \<18 years
Other
- PS \>2
- Presence of distant metastases in sites other than the pelvic lymph nodes
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.