Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Apr 9, 2024
Trial Information
Current as of June 28, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is focused on understanding how treatment for anal cancer affects patients' quality of life. Specifically, it looks at patients who are receiving a type of radiation therapy called intensity-modulated radiotherapy (IMRT) combined with chemotherapy. While this treatment is effective in controlling cancer and preserving important functions, many patients report issues related to their bowel, anal sphincter, and sexual health after treatment. By using questionnaires that patients fill out themselves, the study aims to gather information about their experiences and any challenges they face during and after treatment.
To participate in this study, individuals must be at least 18 years old and diagnosed with squamous cell carcinoma of the anal canal, with limited spread of the cancer at the time of diagnosis. Participants should be able to perform daily activities with some assistance if needed, as determined by a specific scoring system. Those who join the study can expect to share their thoughts and feelings about their quality of life while receiving support and care for their condition. This research could help improve future treatments and care for patients with anal cancer.
Gender
ALL
Eligibility criteria
- 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
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, Lazio, Italy
Patients applied
Trial Officials
Stefania Manfrida
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported