Assessing quality of life in anal cancer patients treated with radiotherapy
Official title: Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT06364579 · Data updated 2026-11-12
This study is trying to see how treatment affects the quality of life for anal cancer patients by having them fill out questionnaires about their symptoms and daily life over five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, Lazio) |
| Status | Recruiting |
| Started | March 28, 2024 |
| Main results expected | January 31, 2027 |
| Study ends | January 31, 2031 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT06364579 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with squamous cell carcinoma of the anal canal who are eligible for radiochemotherapy.
✕Probably not a fit
Patients with metastatic disease at diagnosis not suitable for radiochemotherapy or those with an ECOG performance status higher than 3 may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the quality of life (QOL) of anal cancer patients who have undergone radiochemotherapy by utilizing patient-reported outcomes (PROs). Participants will complete self-administered questionnaires, including the EORTC QLQ-AN27 and QLQ-30, to document their symptoms and functional status before, after, and during follow-ups for up to five years. The study seeks to provide a comprehensive understanding of the long-term effects of treatment on patients' lives, particularly focusing on aspects related to intestinal, anal sphincter, and sexual health. By integrating PROs with physician-assessed toxicity, the study aims to enhance clinical practice and inform future interventions.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies that enhance the quality of life for anal cancer patients post-treatment.
How similar studies have gone: While the use of PROs in cancer treatment is becoming standard, this specific focus on anal cancer and its long-term QOL impacts is relatively novel and underexplored.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, Italy Recruiting
Study contacts
- Principal investigator: Stefania Manfrida — Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Study coordinator: Stefania Manfrida, MD
- Email: stefania.manfrida@policlinicogemelli.it
- Phone: 0039 0630154434
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.