Clinical trial · Observational
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
NCT06398938CI-TRIAL-00093708EROS3recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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+/-).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Cervical Carcinoma | Cervical Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interventional Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Acute and late gastrointestinal toxicity
- timeFrame
- 6 months
- description
- Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
- measure
- Acute and late urinary toxicity
- timeFrame
- 6 months
- description
- Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
- measure
- Sexual activity
- timeFrame
- 6 months
- description
- Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.