Evaluation of Ultraaccelerated High Dose Rate Intrauterine Interventional Radiotherapy

NCT06398938 | Recruiting

• 1 other identifier: 6676
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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+/-).

Conditions

Locally Advanced Cervical Carcinoma

Keywords

cervical carcinoma; interventional radiotherapy; acute and late toxicities; radiochemotherapy

Outcome Measures

Primary Outcomes (3)

• Acute and late gastrointestinal toxicity

  Acute and late toxicities will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy

  6 months

• 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

• Sexual activity

  Sexual activity will evaluated with CTCAE scale to analyze the safety of accelerated interventional radiotherapy

  6 months

Interventions

Interventional Radiotherapy RADIATION

The patients will undergo four IRT fractions in one week

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced cervix cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• VALENTINA LANCELLOTTA

  Fondazione Universiataria Policlinico A Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

VALENTINA LANCELLOTTA

CONTACT

3441177911; valentina.lancellotta@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: May 3, 2024
• Study Start: May 6, 2024
• Primary Completion: May 30, 2025
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

IT (1)