RecruitingNCT06398938

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

129 participants

Start Date

May 6, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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+/-).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a fast, high-dose radiation therapy (brachytherapy) delivered directly inside the uterus as part of treatment for cervical cancer. Researchers want to see if this accelerated approach is as safe and effective as standard treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma or adenocarcinoma of the cervix - Your cancer is at an intermediate to locally advanced stage (FIGO stage IB2 to IVA) - You are able to have an MRI of the pelvis **You may NOT be eligible if...** - You have had cancer in the last 10 years - You have had radiation treatment to the same area before - You have conditions that make radiation risky (such as ulcerative colitis, diverticulitis, or genetic radiosensitivity syndromes) - You have serious organ problems (severe liver, heart, or kidney disease) that prevent chemotherapy - Cancer has spread to distant organs outside the pelvic area Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONInterventional Radiotherapy

The patients will undergo four IRT fractions in one week


Locations(1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Rome, Italy

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NCT06398938


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