Menu
Recruiting NCT06761287

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

No phase Interventional Locally Advanced Rectal Cancer (LARC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endoscopic resection, Short interval restaging, Total mesorectal excision.
Who it may be relevant to
Registry conditions: Locally Advanced Rectal Cancer (LARC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Procedure Endoscopic resection
    Eligible patients will undergo endoscopic submucosal dissection (ESD) or endoscopic intermuscular dissection (EID) after two to eight weeks of nCRT completion, depending on the used neo-adjuvant regimen. Procedures will be performed using the GIF EZ-1500 endoscope (Olympus America, Center Valley, PA, USA) and an electrosurgical unit (VIO 300 D; Erbe, Germany) to power the electrosurgical knife (1.5-mm DualKnife J, Olympus America). For mucosal incision, Endocut or Drycut mode will be used, while
  • Behavioral Short interval restaging
    Close follow-up and endoscopic re-evaluation four to eight weeks after the initial evaluation\*. \*Defined as the first endoscopic evaluation after completion of the neoadjuvant treatment
  • Procedure Total mesorectal excision
    This technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum).

Primary outcome measures

  • Feasibility of Endoscopic Resection [Time frame: From the endoscopic procedure date to the date of reported pathology results, estimated to a maximum of 15 days]
  • Disease Recurrence [Time frame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]
Secondary outcome measures (10)
  • Complete endoscopic resection rate [Time frame: The day of the endoscopic procedure]
  • En-bloc endoscopic resection rate [Time frame: The day of the endoscopic procedure]
  • Incidence of procedure-related technical complications (Safety of the technique) [Time frame: The day of the endoscopic procedure]
  • Incidence of early procedure-related adverse events [Time frame: Starting the next day following the endoscopic procedure until 30 days after the procedure]
  • Incidence of late procedure-related adverse events (Long-term safety of the procedure) [Time frame: From the endoscopic procedure date until 5 years after the procedure date]
  • Endoscopic tumor characteristics [Time frame: From the endoscopic procedure date until 5 years after the procedure date]
  • Pathologic tumor characteristics [Time frame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]
  • Pathological response [Time frame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]
  • Molecular biomarkers [Time frame: From the pathologic report date until 5 years after the endoscopic procedure date]
  • Survival Outcomes [Time frame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • CHU Saint Pierre — Brussels

Identifiers

NCT: NCT06761287 · OPAL202412

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗