Oncological Impact of Lateral Nodes in Rectal Cancer

NCT05592873 | Completed

• 1 other identifier: S_03_11_21_5538
• Study Type: observational
• Target: 317
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Colorectal Adenocarcinoma

Keywords

rectal cancer; cancer of rectum; rectal tumors

Outcome Measures

Primary Outcomes (1)

• Lateral nodal recurrence

  Preoperative MRI feauteres assosiated with lateral nodal recurrence

  3 years

Study Arms (1)

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.

Drug: Neoadjuvant chemoradiotherapy (CRT)

Interventions

Neoadjuvant chemoradiotherapy (CRT) DRUG

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.

Also known as: Total mesorectal excision (TME)

Patients with locally advanced rectal adenocarcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

Sponsors & Collaborators

• Niguarda Hospital: lead
• Mayo Clinic: collaborator

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 25, 2022
• Study Start: January 1, 2014
• Primary Completion: December 31, 2019
• Study Completion: September 30, 2022
• Last Updated: October 25, 2022

Record last verified: 2022-10