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

Recruiting now

Conditions studied: Anal Cancer Patients

In brief

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.

Key facts

Study ID

NCT06364579

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

120

Starts

2024-03-28

Expected to finish

2031-01-31

Last updated by the study team

2025-08-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• age under 18 years
• Eastern Cooperative Oncology Group (ECOG) higher than 3
• metastatic disease at diagnosis not amenable to radiochemotherapy treatment

Where it is running

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Rome, Lazio, Italy (enrolling)

Full record on ClinicalTrials.gov

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