Clinical trial NCT06761287: Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Official title: Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Locally Advanced Rectal Cancer (LARC)
Keywords: locally advanced rectal cancer
neoadjuvant
endoscopic resection
endoscopic submucosal dissection
endoscopic intermuscular dissection
feasibility
safety
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Endoscopic Resection
timeFrame: From the endoscopic procedure date to the date of reported pathology results, estimated to a maximum of 15 days
measure: Disease Recurrence
timeFrame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
Secondary outcomes:
measure: Complete endoscopic resection rate
timeFrame: The day of the endoscopic procedure
measure: En-bloc endoscopic resection rate
timeFrame: The day of the endoscopic procedure
measure: Incidence of procedure-related technical complications (Safety of the technique)
timeFrame: The day of the endoscopic procedure
measure: Incidence of early procedure-related adverse events
timeFrame: Starting the next day following the endoscopic procedure until 30 days after the procedure
measure: Incidence of late procedure-related adverse events (Long-term safety of the procedure)
timeFrame: From the endoscopic procedure date until 5 years after the procedure date
measure: Endoscopic tumor characteristics
timeFrame: From the endoscopic procedure date until 5 years after the procedure date
measure: Pathologic tumor characteristics
timeFrame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
measure: Pathological response
timeFrame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
measure: Molecular biomarkers
timeFrame: From the pathologic report date until 5 years after the endoscopic procedure date
measure: Survival Outcomes
timeFrame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
Other outcomes:
measure: Procedure Duration
timeFrame: The day of the endoscopic procedure
measure: Length of Hospital Stay
timeFrame: From the endoscopic procedure date to the date of the patient's discharge from the hospital, up to 30 days
Locations:
city: Brussels
country: Belgium
facility: CHU Saint Pierre
Study officials:
References: