Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy (EROS3)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Enrolling

Conditions: Locally Advanced Cervical Carcinoma

Treatments: Radiation: Interventional Radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06398938

6676

Details and patient eligibility

About

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+/-).

Full description

Observational, monocentric and prospective study. All patients with locally advanced cervix cancer will be underwent to radiochemotherapy followed by accelerated interventional radiotherapy (brachytherapy). Fist endpoints wer severe acute and late gastrointestinal, and urinary toxicities and sexual activity.

Enrollment: 129 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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