Optimizing Patient Selection for Watch-and-wait Approach Using Pathological Response Analysis Following Neoadjuvant Treatment 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

The goal of this interventional non-randomized prospective trial is to determine the feasibility, efficacy and safety of the endoscopic resection of the residual scar or superficial residual adenomatous tissue following neoadjuvant treatment in locally advanced rectal cancer, as well as to evaluate if the pathological profile analysis after endoscopic resection following neoadjuvant treatment can enhance patients' selection for a "watch-and-wait" strategy.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-31
• Study First Posted: 2025-01-07
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-25
• Study Start: 2025-03-28
• 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 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 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 adenomatous lesions, without features of malignancy 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.
Local 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 recurrence 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
Complete endoscopic resection rate	The day of the endoscopic procedure	This is defined as the absence of residual visible tissue after endoscopic resection
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
Distant Disease Recurrence	From the endoscopic procedure date until 5 years after the procedure date	This will be assessed by evaluating the rate of distant metastasis within 1, 3 and 5 years post-treatment
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.

Trial Locations

Locations (1)

CHU Saint Pierre; 🇧🇪 Brussels, Belgium