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

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.

Study Overview

• Status: Recruiting
• Conditions: Anal Cancer Patients

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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Stefania Manfrida, MD; Phone Number: 0039 0630154434; Email: stefania.manfrida@policlinicogemelli.it
• Study Contact Backup: Name: Stefania Manfrida; Phone Number: +390630155701; Email: stefania.manfrida@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario A. Gemelli IRCCS
      • Contact: Stefania Manfrida, MD; Phone Number: +3900630154434; Email: stefania.manfrida@policlinicogemelli.it
      • Contact: Stefania Mandrida; Phone Number: +390630155701
      • Principal Investigator: Stefania Manfrida, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with anal cancer treated with radiochemotherapy at the Fondazione Policlinico Gemelli from 2010 to the present.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Acute toxicity	Acute toxicity caused by chemoradiation according to CTCAE v. 5.0	during treatment, end of treatment
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

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Stefania Manfrida, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2031

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Estimated): April 15, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: radiotherapy; radiation therapy; QOL; anal cancer; follow up; EORTC; PROs
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Anus Diseases; Anus Neoplasms
• Other Study ID Numbers: 6533

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No