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

Withdrawn

• Conditions: Non Metastatic Rectal Cancer
• Interventions: Other: Registry

• Registration Number: NCT04045236
• Lead Sponsor: Niguarda Hospital

Brief 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

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 Timeline

• Study First Submitted: 2019-07-30
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Study Start: 2021-10-01
• Primary Completion: 2021-12-01
• Study Completion: 2022-09-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non metastatic rectal cancer	Registry	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.

Primary Outcome Measures

Name	Time	Method
Disease free survival	at 5 years from surgery	Survival rate
Over all survival	at 5 years from surgery	Survival rate
Local recurrences	at 5 years from surgery	Recurrences rate
Distant recurrence	at 5 years from surgery	Recurrences rate

Secondary Outcome Measures

Name	Time	Method
Quality of life Scale (QOLS)	at 5 years from surgery	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.

Trial Locations

Locations (1)

ASST Grande Ospedale Metropolitano Niguarda; 🇮🇹 Milano, Italia, Italy