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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06398938
Other study ID # 6676
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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