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

Non Metastatic Rectal Cancer Clinical Trial

— FUCORE  

Official title:

Rectal Cancer AIMS Academy Clinical Research Network Registry

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04045236
• Other study ID #: FUCORE TRIAL
• Status: Withdrawn
• Start date: October 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: March 2023
• Source: Niguarda Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 1, 2022
• Est. primary completion date: December 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Non Metastatic Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• Registry
Data collection

Locations

Country	Name	City	State
Italy	ASST Grande Ospedale Metropolitano Niguarda	Milano	Italia

Sponsors (1)

Lead Sponsor	Collaborator
Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	Survival rate	at 5 years from surgery
Primary	Over all survival	Survival rate	at 5 years from surgery
Primary	Local recurrences	Recurrences rate	at 5 years from surgery
Primary	Distant recurrence	Recurrences rate	at 5 years from surgery
Secondary	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