T4 Colorectal CancerNCT04466696
Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients
An observational study of T4 Colorectal Cancer and ERAS, run by University of Rome Tor Vergata.
Trial summary
Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- T4 Colorectal Cancer, ERAS, Colon Cancer
- What is being tested?
- ERAS protocol
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 82 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 7 Jul 2020
- 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 with a clinical diagnosis of stage T4 colorectal cancer who underwent surgical resection between January 2016 to January 2020 at Minimally Invasive Surgery Unit of Tor Vergata University Hospital were prospectively enrolled in the ERAS group and treated with fast track protocol. Postoperative short outcomes were compared to a control group treated with conventional care that underwent surgical resection for T4 colorectal cancer at the same center from January 2010 to December 2015. Data of the control group were collected retrospectively from a prospectively mantained database.
Who may be able to join
- colorectal cacer
- hystologic diagnosis of adenocarcinoma of the colon/rectum
- clinically staged T4
- written informed consent to surgery obtained
Who cannot join
- pregnancy
- failure to perform colonic or rectal resection
- synchronous cancer at time of colorectal cancer diagnosis
About this study
Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those characteristics makes them to be considered less suitable for ERAS protocol, especially regarding an expected difficult compliance to postoperative items.
The impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded T4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together.
Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary outcome was to compare postoperative lenght of stay between T4 colorectal patients treated with ERAS protcol and those treated with standard of care.
- Conditions
- T4 Colorectal Cancer, ERAS, Colon Cancer, Fast Track Protocol
- Being tested
- ERAS protocol
- Keywords
- colon cancer, ERAS, fast track, t4 colorectal cancer, colorectal cancer
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolBehavioural
items of ERAS protocol applied
| Study group | Role | What they receive |
|---|---|---|
| t4 colorectal cancer treated with ERAS protocol | prospective from January 2016 to May 2020 Receives: Behavioral: ERAS protocol | |
| t4 colorectal cancer treated with standards of care | retrospective from January 2010 to December 2015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative length of stay
number of days from surgery to discharge
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start1 Jan 2016
- Primary completion30 May 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T4 Colorectal 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Sigismondo Sica, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04466696
- Sponsor's protocol ID
- 3
- Status last verified
- Dec 2020
- First submitted
- 7 Jul 2020
- Last updated
- 29 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients
- ClinicalTrials.gov ID
- NCT04466696
- Acronym / sponsor ID
- 3
- Conditions
- T4 Colorectal Cancer, ERAS, Colon Cancer, Fast Track Protocol
- Keywords
- colon cancer, ERAS, fast track, t4 colorectal cancer, colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 10 Jul 2020 (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.
Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.Those characteristics makes them to be considered less suitable for ERAS protocol, especially regarding an expected difficult compliance to postoperative items.
The impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded T4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together.
Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary outcome was to compare postoperative lenght of stay between T4 colorectal patients treated with ERAS protcol and those treated with standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| t4 colorectal cancer treated with ERAS protocol | – | Behavioral: ERAS protocolprospective from January 2016 to May 2020 |
| t4 colorectal cancer treated with standards of care | – | –retrospective from January 2010 to December 2015 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with a clinical diagnosis of stage T4 colorectal cancer who underwent surgical resection between January 2016 to January 2020 at Minimally Invasive Surgery Unit of Tor Vergata University Hospital were prospectively enrolled in the ERAS group and treated with fast track protocol. Postoperative short outcomes were compared to a control group treated with conventional care that underwent surgical resection for T4 colorectal cancer at the same center from January 2010 to December 2015. Data of the control group were collected retrospectively from a prospectively mantained database.
Key inclusion criteria (4 listed)
- colorectal cacer
- hystologic diagnosis of adenocarcinoma of the colon/rectum
- clinically staged T4
- written informed consent to surgery obtained
Key exclusion criteria (3 listed)
- pregnancy
- failure to perform colonic or rectal resection
- synchronous cancer at time of colorectal cancer diagnosis
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 |
|---|---|---|
| ERAS protocolitems of ERAS protocol applied | Behavioural | t4 colorectal cancer treated with ERAS protocol |
Primary outcome
Postoperative length of stay
Time frame: 30 days
number of days from surgery to discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
Related trials for T4 Colorectal Cancer
RecruitingObservational study
A Translational Study for Locoregional Recurrence of T4 Colon Cancer
T4 Colorectal Cancer, Colorectal Cancer Stage III
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.
Questions about this trial
What is this clinical trial studying?
An observational study of T4 Colorectal Cancer and ERAS, run by University of Rome Tor Vergata.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Postoperative length of stay (time frame: 30 days). 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 29 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.