Non Metastatic Rectal CancerFUCORENCT04045236
AIMS Academy Clinical Research Network - Non Metastatic Rectal Cancer Operated on With Curative Intent
An observational study of Non Metastatic Rectal Cancer, run by Niguarda Hospital at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Metastatic Rectal Cancer
- What is being tested?
- Registry
- How many people
- 0 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- non metastatic rectal cancer with the indication for a curative treatment
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Non Metastatic Rectal Cancer
- Being tested
- Registry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RegistryOther
Data collection
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Registry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Survival rate
Measured: at 5 years from surgery
Over all survival
Survival rate
Measured: at 5 years from surgery
Local recurrences
Recurrences rate
Measured: at 5 years from surgery
Distant recurrence
Recurrences rate
Measured: at 5 years from surgery
Secondary outcomes (1)
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.
Measured: at 5 years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start1 Oct 2021
- Primary completion1 Dec 2021
- Study completion1 Sep 2022
Why it stopped: no pts enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Metastatic Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045236
- Sponsor's protocol ID
- FUCORE TRIAL
- Acronym
- FUCORE
- Status last verified
- Mar 2023
- First submitted
- 30 Jul 2019
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal Cancer AIMS Academy Clinical Research Network Registry
- ClinicalTrials.gov ID
- NCT04045236
- Acronym / sponsor ID
- FUCORE / FUCORE TRIAL
- Conditions
- Non Metastatic Rectal Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no pts enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non metastatic rectal cancer | – | Other: RegistryPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- non metastatic rectal cancer with the indication for a curative treatment
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RegistryData collection | Other | Non metastatic rectal cancer |
Primary outcome
Disease free survival
Time frame: at 5 years from surgery
Survival rate
Over all survival
Time frame: at 5 years from surgery
Survival rate
Local recurrences
Time frame: at 5 years from surgery
Recurrences rate
Distant recurrence
Time frame: at 5 years from surgery
Recurrences rate
1 secondary outcome
Quality of life Scale (QOLS)
Time frame: at 5 years from surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Metastatic Rectal Cancer, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: at 5 years from surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.