Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer

Not Applicable

Recruiting

• Conditions: Locally Advanced Rectal Cancer (LARC)

• Registration Number: NCT06761287
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

Brief Summary

This interventional, non-randomized, prospective trial aims to evaluate the role of endoscopic resection following neoadjuvant treatment in patients with locally advanced rectal cancer.

Phase I focuses on assessing the feasibility, safety and efficacy of endoscopic resection of residual scar or superficial residual neoplastic tissue following neoadjuvant treatment.

Phase II explores the potential of this approach to guide patient selection for total mesorectal excision and to serve as a definitive treatment option for those with limited residual disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-07
• Study Start: 2025-03-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-25
• Last Update Posted: 2025-05-30
• Primary Completion: 2030-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Age > 18 years old
• Signed informed consent
• Patients diagnosed with locally advanced rectal cancer showing complete or near-complete clinical response after neoadjuvant therapy without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
• Patients diagnosed with locally advanced rectal cancer showing incomplete response with presence of superficial residual lesions, without invasive features on endoscopic evaluation, without evidence of invasive disease (>T2) or locoregional invasion on magnetic resonance imaging and without any signs of metastatic disease on a computerized tomography scan.
• Without previous medical history of rectal cancer or rectal surgery

Exclusion Criteria

• Previous medical history of rectal cancer
• Previous rectal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of Endoscopic Resection	From the endoscopic procedure date to the date of reported pathology results, estimated to a maximum of 15 days	Feasibility of the endoscopic resection technique in the context of locally advanced rectal cancer treated with neoadjuvant therapy including radio-chemotherapy. This will be assessed by the curative, en-bloc, and R0 resection rates.
Disease Recurrence	From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy	This will be assessed by the rate of local or distant recurrences and the need of salvage surgery within 1, 3 and 5 years following the neoadjuvant treatment and endoscopic resection.

Secondary Outcome Measures

Name	Time	Method
En-bloc endoscopic resection rate	The day of the endoscopic procedure	This is defined as a single piece endoscopic resection, with clear margins
Incidence of procedure-related technical complications (Safety of the technique)	The day of the endoscopic procedure	This will be defined as any complication occuring during the performance of the endoscopic procedure, such as muscle galling, rectal muscle perforation, minor or major bleeding, anesthesia-related adverse events, endoscopic material defect
Incidence of early procedure-related adverse events	Starting the next day following the endoscopic procedure until 30 days after the procedure	This will be assessed by evaluating the incidence of procedure-related adverse events (AEs) and serious adverse events (SAEs) within 30 days post-procedure. This includes bleeding rates, perforation rates, infection rates among other complications.
Incidence of late procedure-related adverse events (Long-term safety of the procedure)	From the endoscopic procedure date until 5 years after the procedure date	This will be assessed by evaluating the incidence of late procedure-related complications within 1, 3 and 5 years after the procedure. This includes delayed haemorrhage, delayed perforation, stenosis, stricture, infection and local pain among other complications
Endoscopic tumor characteristics	From the endoscopic procedure date until 5 years after the procedure date	This will be assessed by the correlation between endoscopic tumor characteristics and the rates of recurrence and salvage surgery. Endoscopic tumor characteristics include the presence of a non-lifting sign, muscle retraction sign, fibrosis, and the description of vessels density (low/moderate/high)
Pathologic tumor characteristics	From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy	This will be assessed by the correlation between residual tumor characteristics (e.g. resected specimen surface, the presence of residual tumor, tumor differentiation, margin status, lymphovascular invasion (LVI), perineural invasion (PNI), fibrosis degree, tumor budding) and the rates of recurrence and salvage surgery
Pathological response	From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy	This will be assessed by the correlation between the degree of pathological response (e.g., complete, partial, or poor response) and the rates of recurrence and salvage surgery
Molecular biomarkers	From the pathologic report date until 5 years after the endoscopic procedure date	This will be assessed by evaluating molecular biomarkers such as Next Generation Sequencing (NGS) on the resected specimen, and correlating these findings with the rates of recurrence and salvage surgery
Survival Outcomes	From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy	Overall survival (OS) and disease-free survival (DFS) at 1, 3 and 5 years.
Complete endoscopic resection rate	The day of the endoscopic procedure	This is defined as the absence of residual visible tissue after endoscopic resection

Trial Locations

Locations (1)

CHU Saint Pierre; 🇧🇪 Brussels, Belgium