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

Anal Cancer Patients Clinical Trial

— PROACT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06364579
• Other study ID #: 6533
• Status: Recruiting
• Start date: March 28, 2024
• Est. completion date: January 31, 2031

Study information

• Verified date: March 2024
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Stefania Manfrida, MD
• Phone: 0039 0630154434
• Email: stefania.manfrida[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: January 31, 2031
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anal Cancer Patients
• Anus Neoplasms

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QOL analysis	Analysis of quality of life (QOL) by administration of PRO questionnaires to patients with cancer of the anus treated with IMRT radiochemotherapy.	60 months from the last enrolled patient (january 2026)
Secondary	Overall survival (OS)	Absence of death from any cause.	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
Secondary	Colostomy Free Survival (CFS)	Being alive without a temporary or permanent ileostomy or colostomy	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
Secondary	Loco-Regional Recurrence (LRR)	Presence of disease progression inside the target volume of radiation therapy	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
Secondary	Disease-Free Survival (DFS)	The time from last treatment to cancer recurrence or death from any cause	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
Secondary	Acute toxicity	Acute toxicity caused by chemoradiation according to CTCAE v. 5.0	during treatment, end of treatment
Secondary	Late toxicity	Late toxicity caused by chemoradiation according to CTCAE v. 5.0	6 month post treatment ,1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up