## Protocol Section
### Identification Module
**NCT ID:** NCT06364579

**Acronym:** PROACT

**Brief Title:** 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).

#### Organization Study ID Info
**ID:** 6533
#### Organization
**Class:** OTHER
**Full Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS
### Status Module
#### Completion Date
**Date:** 2031-01-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-15

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-09

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2027-01-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-28

**Type:** ACTUAL

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-04-15
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-28
**Study First Submit QC Date:** 2024-04-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Fondazione Policlinico Universitario Agostino Gemelli IRCCS

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Anal Cancer Patients

**Keywords:**

- PROs

- QOL

- EORTC

- anal cancer

- radiotherapy

- radiation therapy

- follow up

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** OTHER

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Analysis of quality of life (QOL) by administration of PRO questionnaires to patients with cancer of the anus treated with IMRT radiochemotherapy.

**Measure:** QOL analysis

**Time Frame:** 60 months from the last enrolled patient (january 2026)

#### Secondary Outcomes

**Description:** Absence of death from any cause.

**Measure:** Overall survival (OS)

**Time Frame:** 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

**Description:** Being alive without a temporary or permanent ileostomy or colostomy

**Measure:** Colostomy Free Survival (CFS)

**Time Frame:** 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

**Description:** Presence of disease progression inside the target volume of radiation therapy

**Measure:** Loco-Regional Recurrence (LRR)

**Time Frame:** 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

**Description:** The time from last treatment to cancer recurrence or death from any cause

**Measure:** Disease-Free Survival (DFS)

**Time Frame:** 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

**Description:** Acute toxicity caused by chemoradiation according to CTCAE v. 5.0

**Measure:** Acute toxicity

**Time Frame:** during treatment, end of treatment

**Description:** Late toxicity caused by chemoradiation according to CTCAE v. 5.0

**Measure:** Late toxicity

**Time Frame:** 6 month post treatment ,1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** stefania.manfrida@policlinicogemelli.it

**Name:** Stefania Manfrida, MD

**Phone:** 0039 0630154434

**Role:** CONTACT

**Contact 2:**

**Email:** stefania.manfrida@policlinicogemelli.it

**Name:** Stefania Manfrida

**Phone:** +390630155701

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Rome

**Contacts:**

***Contact 1:***

- **Email:** stefania.manfrida@policlinicogemelli.it

- **Name:** Stefania Manfrida, MD

- **Phone:** +3900630154434

- **Role:** CONTACT

***Contact 2:***

- **Name:** Stefania Mandrida

- **Phone:** +390630155701

- **Role:** CONTACT

***Contact 3:***

- **Name:** Stefania Manfrida, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Italy

**Facility:** Fondazione Policlinico Universitario A. Gemelli IRCCS

**State:** Lazio

**Status:** RECRUITING

**Zip:** 00168

#### Overall Officials

**Official 1:**

**Affiliation:** Fondazione Policlinico Universitario A. Gemelli, IRCCS

**Name:** Stefania Manfrida

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012004

- Term: Rectal Neoplasms

- ID: D000015179

- Term: Colorectal Neoplasms

- ID: D000007414

- Term: Intestinal Neoplasms

- ID: D000005770

- Term: Gastrointestinal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000001004

- Term: Anus Diseases

- ID: D000012002

- Term: Rectal Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M4321

- Name: Anus Neoplasms

- Relevance: HIGH

- As Found: Anal Cancer

- ID: M14846

- Name: Rectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M17890

- Name: Colorectal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10448

- Name: Intestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4320

- Name: Anus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14844

- Name: Rectal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T362

- Name: Anal Cancer

- Relevance: HIGH

- As Found: Anal Cancer

### Condition Browse Module - Meshes

- ID: D000001005

- Term: Anus Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
