Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

Locally Advanced Cervical Carcinoma Clinical Trial

— EROS3  

Official title:

EROS 3 Study Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy Brachytherapy in Terms of Overall Toxicity and Sexual Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06398938
• Other study ID #: 6676
• Status: Not yet recruiting
• Start date: May 6, 2024
• Est. completion date: December 30, 2026

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: VALENTINA LANCELLOTTA
• Phone: 3441177911
• Email: valentina.lancellotta[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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+/-).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 129
• Est. completion date: December 30, 2026
• Est. primary completion date: May 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Locally Advanced Cervical Carcinoma

Intervention

Radiation:
• Interventional Radiotherapy
The patients will undergo four IRT fractions in one week

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute and late gastrointestinal toxicity	Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy	6 months
Primary	Acute and late urinary toxicity	Acute and late urinary toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy	6 months
Primary	Sexual activity	Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy	6 months