Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belgium
CHU Saint Pierre
RECRUITING
Brussels
Contact Information
Primary
Mariana Figueiredo
mariana.figueiredo@stpierre-bru.be
+32 23533332
Backup
Amélie Deleporte
amelie.deleporte@stpierre-bru.be
+32 25354144
Time Frame
Start Date: 2025-03-28
Estimated Completion Date: 2030-12
Participants
Target number of participants: 20
Treatments
Experimental: Complete clinical response
Defined as the presence of residual clear scar seen on endoscopic examination, 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.
Experimental: Near complete clinical response
Defined as the presence of irregular mucosa or small mucosal nodules or superficial ulceration or persisting erythema of the scar seen on endoscopic examination, 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.
Experimental: Incomplete response with presence of superficial residual tissue
Defined as the presence of superficial residual tissue without features of deep invasion seen on endoscopic examination, 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.
Active_comparator: No significant response
Persistant local signs of malignancy
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Universitaire Saint Pierre

This content was sourced from clinicaltrials.gov