Clinical trial NCT06364579: Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).
Official title: Patient Reported Outcomes (PROs) in Anal Cancer Patient Treated by Intensity Modulated Radiotherapy (IMRT).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anal Cancer Patients
Keywords: PROs
QOL
EORTC
anal cancer
radiotherapy
radiation therapy
follow up
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with anal cancer treated with radiochemotherapy at the Fondazione Policlinico Gemelli from 2010 to the present.

Brief 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.

Detailed description: In recent times, the focus on collecting patient-reported outcomes (PROs) has increased in healthcare. The Food and Drug Administration defines PROs as a -measurement of any aspect of a health status of the patient that comes directly from the patient-. These includes disease symptoms, functional aspects and quality of life (QOL). The collection of PROs, combined with physician-assessed toxicity, is constantly being incorporated into clinical practice and studies to provide a more holistic picture of the impact of treatment on patients and prove useful for planning future interventions. Although the use of PROs has now become the standard for measuring quality of life of patients there are still few studies on the self-reported long-term QOL of anal cancer patients and on disease or therapy related symptoms that affect QOL. Therefore, the EORTC (European Organisation for Research and Treatment of Cancer) has recently developed the specific Quality of Life Questionnaire for anal cancer (QLQ-AN27) module to explore typical symptoms of anal cancer and its therapy. In this study, the QLQ-AN27 questionnaire will be administered together with the EORTC Quality of Life 30 (QLQ 30) in patients with anal cancer who have undergone radio-chemotherapy. The questionnaire may be administered before treatment, after treatment and during follow-ups until completion of the fifth year. This is an observational study both retrospective and prospective.

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

Primary outcomes:
measure: QOL analysis
timeFrame: 60 months from the last enrolled patient (january 2026)
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up
measure: Colostomy Free Survival (CFS)
timeFrame: time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up
measure: Loco-Regional Recurrence (LRR)
timeFrame: time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up
measure: Disease-Free Survival (DFS)
timeFrame: time 0, end of treatment, 6 month post treatment, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up
measure: Acute toxicity
timeFrame: during treatment, end of treatment
measure: Late toxicity
timeFrame: 6 month post treatment ,1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Stefania Manfrida
role: PRINCIPAL_INVESTIGATOR
References: