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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: valentina.lancellotta@policlinicogemelli.it
• Phone: 3441177911

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.