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Clinical Trials in Italy / NCT06364579
Recruiting Observational

Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).

NCT06364579 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2024-03-28
Last updated
2025-08-26

Condition(s) studied

Anal Cancer Patients

Study summary

Radiochemotherapy is the standard treatment for neoplasms of the anal canal with excellent rates of local control and preservation of the anal sphincter. However, patients may experience a deterioration of quality of life related to sequelae of the treatment particularly at intestinal, anal sphincter and sexual level. Few studies to date have documented patient-reported outcomes (PROs) in this area. The aim of this observational study is to verify the quality of life (QOL) of the patients by means of self-completed questionnaires.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) 0-3 * minimum 18 years old * squamous cell carcinoma of the anal canal * low burden of metastatic disease at diagnosis * indication for radiochemotherapy treatment * informed consent Exclusion Criteria: * age under 18 years * Eastern Cooperative Oncology Group (ECOG) higher than 3 * metastatic disease at diagnosis not amenable to radiochemotherapy treatment

Primary outcome measure(s)

  • QOL analysis — 60 months from the last enrolled patient (january 2026)
    Analysis of quality of life (QOL) by administration of PRO questionnaires to patients with cancer of the anus treated with IMRT radiochemotherapy.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario A. Gemelli IRCCS Rome Lazio Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06364579 on ClinicalTrials.gov ↗ ← All trials in Italy