Anal Cancer Patients
Conditions
Keywords
PROs, QOL, EORTC, anal cancer, radiotherapy, radiation therapy, follow up
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.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| QOL analysis | 60 months from the last enrolled patient (january 2026) | Analysis of quality of life (QOL) by administration of PRO questionnaires to patients with cancer of the anus treated with IMRT radiochemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colostomy Free Survival (CFS) | 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 | Being alive without a temporary or permanent ileostomy or colostomy |
| Loco-Regional Recurrence (LRR) | 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 | Presence of disease progression inside the target volume of radiation therapy |
| Overall survival (OS) | 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 | Absence of death from any cause. |
| Acute toxicity | during treatment, end of treatment | Acute toxicity caused by chemoradiation according to CTCAE v. 5.0 |
| Late toxicity | 6 month post treatment ,1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up | Late toxicity caused by chemoradiation according to CTCAE v. 5.0 |
| Disease-Free Survival (DFS) | 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 | The time from last treatment to cancer recurrence or death from any cause |
Countries
Italy
Contacts
Primary ContactStefania Manfrida, MD
Backup ContactStefania Manfrida
Outcome results
None listed