Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

Not yet recruiting

• Conditions: Locally Advanced Cervical Carcinoma

• Registration Number: NCT06398938
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief 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+/-).

Detailed 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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-24
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Study Start: 2024-05-06
• Primary Completion: 2025-05-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 129

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acute and late gastrointestinal toxicity	6 months	Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Acute and late urinary toxicity	6 months	Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy
Sexual activity	6 months	Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy