AIMS Academy Clinical Research Network - Non Metastatic Rectal Cancer Operated on With Curative Intent (FUCORE)

Rectal Cancer AIMS Academy Clinical Research Network Registry

The primary purpose of this registry is to prospectively collect data from different Mini-invasive Colo-rectal Units in Northern Italy with a standardization of the pre-operative, intra-operative and post operative setting for patients operated on for non metastatic rectal cancer with curative intent. The secondary aim is to collect in a registry the compliance to oncological treatments and the oncological outcomes for the same patients

Study Overview

• Status: Withdrawn
• Conditions: Non Metastatic Rectal Cancer
• Intervention / Treatment: Other: Registry

Detailed Description

Study parameters

Patients with an histological diagnosis of rectal cancer will undergo pre-operative staging as follow:

• Chest-Abdominal TC scan with e.v. contrast.
• Complete colonoscopy
• Pelvic MRI with e.v. contrast with measurements of all the tumours aspects.
• Endorectal US examination
• Serum level of CEA and CA 19,9 and full nutritional status will be analysed
• Complete oncological and pathological medical history examination.
• Data from place of birth and places where patients lived will be collected.
• Sex and race Charlson Comorbidities Index adjusted for age will be calculated for each patient while Robinson Score will be calculated for aged over 70 patients.

Symptoms at presentation (Haemorrhagic framework ,alvo alteration, pain) will be collected. For Locally advance rectal cancer neo adjuvant chemoradiotherapy will be planned. Grey dose received and total dose of chemotherapy administrated together with eventual toxicity and reasons for non completing the therapy will be collected. Patients will be re-staged with pelvic MRI, endorectal US, colonoscopy. Radiological and endoscopic disease response to neo adjuvant treatment criteria will be noted.

Intraoperative analysed parameters will include :

• time of surgery
• blood loss
• type of analgesia
• type of technique, conversion
• level of IMA ligation
• if splenic flexure lowered down
• type of energy device used
• number and type of cartridge used for rectal stapled line
• size of circular stapler used for the anastomosis
• if loop ileostomy performed Isto-pathological examination will performed according to WHO 2010 guidelines, Quirke score and Dworak grade in patients who will undergo neo adjuvant chemo-radiation therapy will be reported. Mismatch repair proteins will be reported when analysed.

Post operative complication will be described according to Clavien Dindo complication scale. Day of discharge and eventual post discharge complication will be evaluated. Application of an ERAS protocol will be added only for at least 80% of ERAS colo-rectal items satisfied. Indication to eventual adjuvant therapy given within a multidisciplinary setting will be noted. Type of therapy, duration of the treatment and a full description of the compliance to the treatment will be described. Oncological follow up will be performed according to National Comprehensive Cancer Network guidelines. Functional follow up will be done yearly with the Low Anterior Resection Syndrome Score.

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Giovanni Ferrari, MD; Phone Number: 4504 0039026444; Email: giovanni.ferrari@ospedaleniguarda.it
• Study Contact Backup: Name: Matteo Origi, MD; Phone Number: 4302 0039026444; Email: matteo.origi@ospedaleniguarda.it

Study Locations

• Italy
  • Italia
    • Milano, Italia, Italy, 20162
      • Asst Grande Ospedale Metropolitano Niguarda
      • Contact: Matteo Origi, MD; Phone Number: 4302 0039026444; Email: matteo.origi@ospedaleniguarda.it
      • Contact: Jacopo Crippa, MD; Phone Number: 4303 0039026444; Email: jack0510@icloud.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving the diagnosis of non metastatic rectal cancer and the indication for a curative treatment will be enrolled in the registry. The study population will consist of all the patients enrolled in the participating centres from the start of the rectal cancer registry on.

Description

Inclusion Criteria:

• non metastatic rectal cancer with the indication for a curative treatment

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Non metastatic rectal cancer; Patients receiving the diagnosis of non metastatic rectal cancer and the indication for a curative treatment will be enrolled in the registry. The study population will consist of all the patients enrolled in the participating centres from the start of the rectal cancer registry on.	Other: Registry; Data collection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Survival rate	at 5 years from surgery
Over all survival	Survival rate	at 5 years from surgery
Local recurrences	Recurrences rate	at 5 years from surgery
Distant recurrence	Recurrences rate	at 5 years from surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life Scale (QOLS)	QOLS CRC-specific questionnaire FACT-C score analisys. QOLS CRC Range: 7 maximum 1 minimum. 7 score represents a better value. FACT-C Range maximum 4 minimum 0. 4 score represents better value.	at 5 years from surgery

Collaborators and Investigators

• Sponsor: Niguarda Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: July 30, 2019
• First Submitted That Met QC Criteria: August 2, 2019
• First Posted (Actual): August 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 23, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• 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
• Other Study ID Numbers: FUCORE TRIAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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