Clinical trial · Interventional
Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Rectal Cancer (LARC) | Malignant Rectal Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic resection | Procedure | — | UNRESOLVED |
| Short interval restaging | Behavioral | — | UNRESOLVED |
| Total mesorectal excision | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Complete clinical response
- description
- 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.
- interventionNames
- Procedure: Endoscopic resection
- type
- EXPERIMENTAL
- label
- Near complete clinical response
- description
- 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.
- interventionNames
- Procedure: Endoscopic resection
- Behavioral: Short interval restaging
- Procedure: Total mesorectal excision
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available