RecruitingNCT06364579

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


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

120 participants

Start Date

Mar 28, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

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

Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, Italy

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NCT06364579