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

NCT06761287 | Recruiting

• 1 other identifier: OPAL202412
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced Rectal Cancer (LARC)

Keywords

locally advanced rectal cancer; neoadjuvant; endoscopic resection; endoscopic submucosal dissection; endoscopic intermuscular dissection; feasibility; safety

Outcome Measures

Primary Outcomes (2)

• Feasibility of Endoscopic Resection

  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.

  From the endoscopic procedure date to the date of reported pathology results, estimated to a maximum of 15 days

• Disease Recurrence

  This will be assessed by the rate of local or distant recurrences and the need of salvage surgery within 1, 3 and 5 years following the neoadjuvant treatment and endoscopic resection.

  From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy

Secondary Outcomes (10)

• Complete endoscopic resection rate

  The day of the endoscopic procedure

• En-bloc endoscopic resection rate

  The day of the endoscopic procedure

• Incidence of procedure-related technical complications (Safety of the technique)

  The day of the endoscopic procedure

• Incidence of early procedure-related adverse events

  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)

  From the endoscopic procedure date until 5 years after the procedure date

Other Outcomes (2)

• Procedure Duration

  The day of the endoscopic procedure

• Length of Hospital Stay

  From the endoscopic procedure date to the date of the patient's discharge from the hospital, up to 30 days

Study Arms (4)

Complete clinical response

EXPERIMENTAL

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.

Procedure: Endoscopic resection

Near complete clinical response

EXPERIMENTAL

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.

Procedure: Endoscopic resection; Behavioral: Short interval restaging; Procedure: Total mesorectal excision

Incomplete response with presence of superficial residual tissue

EXPERIMENTAL

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.

Procedure: Endoscopic resection; Behavioral: Short interval restaging; Procedure: Total mesorectal excision

No significant response

ACTIVE COMPARATOR

Persistant local signs of malignancy

Procedure: Total mesorectal excision

Interventions

Endoscopic resection PROCEDURE

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 Precise, Swift or Spray Coagulation modes will support submucosal dissection and hemostasis. An initial submucosal lift will be created by Glycéol Gel injection. The ERBE Flushing Pump (Erbe, Germany) will supply further submucosal lift during dissection through foot pedal-controlled, pressurized injections of methylene blue and saline solution delivered via the DualKnife J's ceramic-tipped tubing.

Complete clinical response; Incomplete response with presence of superficial residual tissue; Near complete clinical response

Short interval restaging BEHAVIORAL

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

Incomplete response with presence of superficial residual tissue; Near complete clinical response

Total mesorectal excision PROCEDURE

This technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum).

Incomplete response with presence of superficial residual tissue; Near complete clinical response; No significant response

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous medical history of rectal cancer
• Previous rectal surgery

Sponsors & Collaborators

• Centre Hospitalier Universitaire Saint Pierre: lead

Study Sites (1)

CHU Saint Pierre

Brussels, 1000, Belgium

RECRUITING

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Mariana Figueiredo

CONTACT

+32 23533332; mariana.figueiredo@stpierre-bru.be

Amélie Deleporte

CONTACT

+32 25354144; amelie.deleporte@stpierre-bru.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Gastroenterology, Therapeutic Endoscopy and Digestive Oncology)

Study Record Dates

• First Submitted: December 20, 2024
• First Posted: January 7, 2025
• Study Start: March 28, 2025
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 30, 2025

Record last verified: 2025-05

Locations

BE (1)