Colorectal AdenocarcinomaI-ONARCNCT05592873
Oncological Impact of Lateral Nodes in Rectal Cancer
An observational study of Colorectal Adenocarcinoma, run by Niguarda Hospital.
Trial summary
The combination of neoadjuvant chemoradiotherapy (CRT) and total mesorectal excision (TME) is considered the standard treatment for locally advanced rectal cancer in the western world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Adenocarcinoma
- What is being tested?
- Neoadjuvant chemoradiotherapy (CRT)
- How many people
- 317 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 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
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes patients diagnosed with rectal cancer locally advanced, subjected to Chemo-Radiotherapy and surgical treatment with intent curative between January 2013 and December 2019, in each of the Centers involved. The data they will be collected from medical records and institutional data collection and follow-up databases
Who may be able to join
- Aged 18 years and older
- Histological diagnosis of locally advanced rectal adenocarcinoma [clinical T3-T4N0M0 or T(any)N+M0] treated with neoadjuvant CRT followed by curative intent elective surgery
- Esclusion criteria
- No MRI or pathologic data
- Histological diagnosis other than adenocarcinoma
- Urgent or emergency surgery
- Surgery without curative intent
Who cannot join
None listed.
About this study
Official title: Lateral Lymph Node Features and Tumor Regression Grade After Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: Impact on Oncological Outcomes.
The combination of neoadjuvant chemoradiotherapy (CRT) and total mesorectal excision (TME) is considered the standard treatment for locally advanced rectal cancer in the western world. Appropriate preoperative treatment and margin free surgery are key-elements in reducing the local-recurrence of the tumor and consequently improving overall survival.
Nevertheless, the local recurrence of stage II and III rectal cancer is still high, with current levels of 5% to 10% even when R0 resection is achieved. Most of the cases of loco-regional recurrence are associated with lateral lymph nodes (LLN) spread of cancer cells, which is not always controlled by the preoperative chemotherapy. As a matter of fact, the incidence of LLD metastases has been estimated to range from 11% to 22% in patients with T3/4 rectal cancer below the peritoneal reflection.
Read more
In order to improve these poor outcomes, Japanese surgeons have adopted extended lymphadenectomy with the dissection of lateral extramesorectal lymph nodes as the standard of care for T2-3 low rectal cancer patients5. While this approach is widely used in Japan and Korea, western surgeons have preferred a less aggressive approach, indicating lateral lymph node dissection (LLND) only in presence of clinically highly suspicious lateral pelvic lymph nodes on baseline magnetic resonance imaging (MRI). Thus, it is essential to identify preoperative predictive factors of LLN metastasis.
Even if MRI is considered the optimal diagnostic tool in rectal cancer, its accuracy for LLN staging is considered poor, especially after neoadjuvant treatment. LLNs often change in both features and size after CRT, and this behaviour might not be in concordance with the response of the primary tumor.
To the best of our knowledge, no consensus exists on whether the risk of local recurrence should be determined by assessing the features of LLN on the primary MRI or on the restaging MRI. Moreover, the relation between LLN response and primary tumor regression grade after neoadjuvant CRT needs to be thoroughly explored.
This multicenter cohort study aimed to investigate factors on primary and restaging MRI associated with lateral nodal recurrence and to identify patients who may benefit from LLND after neoadjuvant treatment for locally advanced rectal cancer.
Read the detailed description
The present is an international multicenter observational retrospective study. All consecutive patients admitted with a histologically confirmed locally advanced rectal adenocarcinoma [clinical T3-T4N0M0 or T(any)N+M0] treated with neoadjuvant CRT followed by curative intent elective surgery between January 2014 and December 2019 at four academic high-volume institutions: the Division of Colon and Rectal Surgery, Mayo Clinic, Rochester (MN), USA; the Department of Visceral Surgery, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland; the Division of Minimally-Invasive Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy, and the Division of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano - Milan.
All included patients had a pelvic MRI at baseline and a second pelvic MRI after neoadjuvant CRT. Interpretation and reporting of MRI for baseline staging was performed through a structured report adopted by each center involved in the present study. All MRI reports were presented according to international standards and validated by board-certified specialized lower gastrointestinal radiologists.
- Conditions
- Colorectal Adenocarcinoma
- Being tested
- Neoadjuvant chemoradiotherapy (CRT)
- Keywords
- rectal cancer, cancer of rectum, rectal tumors
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoadjuvant chemoradiotherapy (CRT)Drug
Also called Total mesorectal excision (TME)
Patients with histological diagnosis of locally advanced rectal adenocarcinoma [clinical T3-T4N0M0 or T(any)N+M0] were treated with neoadjuvant CRT followed by curative intent elective surgery between January 2014 and December 2019.
| Study group | Role | What they receive |
|---|---|---|
| Patients with locally advanced rectal adenocarcinoma | Patients with histollogically confirmed locally advanced rectal adenocarcinoma (clinical T3-T4N0M0 or T(any) N+M0) treated with neoadjuvant CRT followed by curtive intent elective surgery. Receives: Drug: Neoadjuvant chemoradiotherapy (CRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lateral nodal recurrence
Preoperative MRI feauteres assosiated with lateral nodal recurrence
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2022
- Study start1 Jan 2014
- Primary completion31 Dec 2019
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal AdenocarcinomaStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mayo Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05592873
- Sponsor's protocol ID
- S_03_11_21_5538
- Acronym
- I-ONARC
- Status last verified
- Oct 2022
- First submitted
- 20 Oct 2022
- Last updated
- 25 Oct 2022
- 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 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lateral Lymph Node Features and Tumor Regression Grade After Neoadjuvant Chemoradiotherapy for Locally Advanced Rectal Cancer: Impact on Oncological Outcomes.
- ClinicalTrials.gov ID
- NCT05592873
- Acronym / sponsor ID
- I-ONARC / S_03_11_21_5538
- Conditions
- Colorectal Adenocarcinoma
- Keywords
- rectal cancer, cancer of rectum, rectal tumors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Collaborators
- Mayo Clinic
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 25 Oct 2022 (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 combination of neoadjuvant chemoradiotherapy (CRT) and total mesorectal excision (TME) is considered the standard treatment for locally advanced rectal cancer in the western world. Appropriate preoperative treatment and margin free surgery are key-elements in reducing the local-recurrence of the tumor and consequently improving overall survival.
Nevertheless, the local recurrence of stage II and III rectal cancer is still high, with current levels of 5% to 10% even when R0 resection is achieved. Most of the cases of loco-regional recurrence are associated with lateral lymph nodes (LLN) spread of cancer cells, which is not always controlled by the preoperative chemotherapy. As a matter of fact, the incidence of LLD metastases has been estimated to range from 11% to 22% in patients with T3/4 rectal cancer below the peritoneal reflection.
In order to improve these poor outcomes, Japanese surgeons have adopted extended lymphadenectomy with the dissection of lateral extramesorectal lymph nodes as the standard of care for T2-3 low rectal cancer patients5. While this approach is widely used in Japan and Korea, western surgeons have preferred a less aggressive approach, indicating lateral lymph node dissection (LLND) only in presence of clinically highly suspicious lateral pelvic lymph nodes on baseline magnetic resonance imaging (MRI). Thus, it is essential to identify preoperative predictive factors of LLN metastasis.
Even if MRI is considered the optimal diagnostic tool in rectal cancer, its accuracy for LLN staging is considered poor, especially after neoadjuvant treatment. LLNs often change in both features and size after CRT, and this behaviour might not be in concordance with the response of the primary tumor.
To the best of our knowledge, no consensus exists on whether the risk of local recurrence should be determined by assessing the features of LLN on the primary MRI or on the restaging MRI. Moreover, the relation between LLN response and primary tumor regression grade after neoadjuvant CRT needs to be thoroughly explored.
This multicenter cohort study aimed to investigate factors on primary and restaging MRI associated with lateral nodal recurrence and to identify patients who may benefit from LLND after neoadjuvant treatment for locally advanced rectal cancer.
Detailed description
The present is an international multicenter observational retrospective study. All consecutive patients admitted with a histologically confirmed locally advanced rectal adenocarcinoma [clinical T3-T4N0M0 or T(any)N+M0] treated with neoadjuvant CRT followed by curative intent elective surgery between January 2014 and December 2019 at four academic high-volume institutions: the Division of Colon and Rectal Surgery, Mayo Clinic, Rochester (MN), USA; the Department of Visceral Surgery, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland; the Division of Minimally-Invasive Surgery, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy, and the Division of Colon and Rectal Surgery, IRCCS Humanitas Research Hospital, Rozzano - Milan.
All included patients had a pelvic MRI at baseline and a second pelvic MRI after neoadjuvant CRT. Interpretation and reporting of MRI for baseline staging was performed through a structured report adopted by each center involved in the present study. All MRI reports were presented according to international standards and validated by board-certified specialized lower gastrointestinal radiologists.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with locally advanced rectal adenocarcinoma | – | Drug: Neoadjuvant chemoradiotherapy (CRT)Patients with histollogically confirmed locally advanced rectal adenocarcinoma (clinical T3-T4N0M0 or T(any) N+M0) treated with neoadjuvant CRT followed by curtive intent elective surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patients diagnosed with rectal cancer locally advanced, subjected to Chemo-Radiotherapy and surgical treatment with intent curative between January 2013 and December 2019, in each of the Centers involved. The data they will be collected from medical records and institutional data collection and follow-up databases
Key inclusion criteria (7 listed)
- Aged 18 years and older
- Histological diagnosis of locally advanced rectal adenocarcinoma [clinical T3-T4N0M0 or T(any)N+M0] treated with neoadjuvant CRT followed by curative intent elective surgery
- Esclusion criteria
- No MRI or pathologic data
- Histological diagnosis other than adenocarcinoma
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Neoadjuvant chemoradiotherapy (CRT)Also: Total mesorectal excision (TME)Patients with histological diagnosis of locally advanced rectal adenocarcinoma [clinical T3-T4N0M0 or T(any)N+M0] were treated with neoadjuvant CRT followed by curative intent elective surgery between January 2014 and December 2019. | Drug | Patients with locally advanced rectal adenocarcinoma |
Primary outcome
Lateral nodal recurrence
Time frame: 3 years
Preoperative MRI feauteres assosiated with lateral nodal recurrence
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 25 Oct 2022.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Adenocarcinoma, run by Niguarda Hospital.
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 7 inclusion and 0 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 25 Oct 2022. 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?
Lateral nodal recurrence (time frame: 3 years). 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 25 Oct 2022.