Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).
Recruiting · NCT06364579 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Rome, Lazio, Italy