Locally Advanced Rectal Cancer (LARC)OPALNCT06761287
Optimizing Patient Selection for Surgery Using Pathologic Analysis Following Neoadjuvant Therapy in Locally Advanced Rectal Cancer
A study testing Endoscopic resection, Short interval restaging and Total mesorectal excision in people with Locally Advanced Rectal Cancer (LARC), run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced Rectal Cancer (LARC)
- What is being tested?
- Endoscopic resection, Short interval restaging and Total mesorectal excision
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 28 Mar 2025to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Previous medical history of rectal cancer
- Previous rectal surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHU Saint Pierre
Brussels, 1000
Mariana Figueiredo, Medical doctor, +32 25353332, mariana.figueiredo@stpierre-bru.be
About this study
Official title: Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study
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)
- Being tested
- Endoscopic resection, Short interval restaging, Total mesorectal excision
- Keywords
- locally advanced rectal cancer, neoadjuvant, endoscopic resection, endoscopic submucosal dissection, endoscopic intermuscular dissection, feasibility, safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic resectionProcedure or surgery
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.
Short interval restagingBehavioural
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
Total mesorectal excisionProcedure or surgery
This technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Endoscopic resection; Behavioral: Short interval restaging; Procedure: Total mesorectal excision |
| No significant response | Active comparator | Persistant local signs of malignancy Receives: Procedure: Total mesorectal excision |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
Secondary outcomes (10)
Complete endoscopic resection rate
This is defined as the absence of residual visible tissue after endoscopic resection
Measured: The day of the endoscopic procedure
En-bloc endoscopic resection rate
This is defined as a single piece endoscopic resection, with clear margins
Measured: The day of the endoscopic procedure
Incidence of procedure-related technical complications (Safety of the technique)
This will be defined as any complication occuring during the performance of the endoscopic procedure, such as muscle galling, rectal muscle perforation, minor or major bleeding, anesthesia-related adverse events, endoscopic material defect
Measured: The day of the endoscopic procedure
Incidence of early procedure-related adverse events
This will be assessed by evaluating the incidence of procedure-related adverse events (AEs) and serious adverse events (SAEs) within 30 days post-procedure. This includes bleeding rates, perforation rates, infection rates among other complications.
Measured: 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)
This will be assessed by evaluating the incidence of late procedure-related complications within 1, 3 and 5 years after the procedure. This includes delayed haemorrhage, delayed perforation, stenosis, stricture, infection and local pain among other complications
Measured: From the endoscopic procedure date until 5 years after the procedure date
Endoscopic tumor characteristics
This will be assessed by the correlation between endoscopic tumor characteristics and the rates of recurrence and salvage surgery. Endoscopic tumor characteristics include the presence of a non-lifting sign, muscle retraction sign, fibrosis, and the description of vessels density (low/moderate/high)
Measured: From the endoscopic procedure date until 5 years after the procedure date
Pathologic tumor characteristics
This will be assessed by the correlation between residual tumor characteristics (e.g. resected specimen surface, the presence of residual tumor, tumor differentiation, margin status, lymphovascular invasion (LVI), perineural invasion (PNI), fibrosis degree, tumor budding) and the rates of recurrence and salvage surgery
Measured: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
Pathological response
This will be assessed by the correlation between the degree of pathological response (e.g., complete, partial, or poor response) and the rates of recurrence and salvage surgery
Measured: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
Molecular biomarkers
This will be assessed by evaluating molecular biomarkers such as Next Generation Sequencing (NGS) on the resected specimen, and correlating these findings with the rates of recurrence and salvage surgery
Measured: From the pathologic report date until 5 years after the endoscopic procedure date
Survival Outcomes
Overall survival (OS) and disease-free survival (DFS) at 1, 3 and 5 years.
Measured: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start28 Mar 2025
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced Rectal Cancer (LARC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Figueiredo, Centre Hospitalier Universitaire Saint Pierre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761287
- Sponsor's protocol ID
- OPAL202412
- Acronym
- OPAL
- Status last verified
- May 2025
- First submitted
- 20 Dec 2024
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study
- ClinicalTrials.gov ID
- NCT06761287
- Acronym / sponsor ID
- OPAL / OPAL202412
- Conditions
- Locally Advanced Rectal Cancer (LARC)
- Keywords
- locally advanced rectal cancer, neoadjuvant, endoscopic resection, endoscopic submucosal dissection, endoscopic intermuscular dissection, feasibility, safety
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire Saint PierreUniversity, hospital or other
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Complete clinical response | Experimental | Procedure: Endoscopic resectionDefined 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. |
| Near complete clinical response | Experimental | Procedure: Endoscopic resection, Behavioral: Short interval restaging, Procedure: Total mesorectal excisionDefined 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. |
| Incomplete response with presence of superficial residual tissue | Experimental | Procedure: Endoscopic resection, Behavioral: Short interval restaging, Procedure: Total mesorectal excisionDefined 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. |
| No significant response | Active comparator | Procedure: Total mesorectal excisionPersistant local signs of malignancy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Previous medical history of rectal cancer
- Previous rectal surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic resectionEligible 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. | Procedure or surgery | Complete clinical response, Incomplete response with presence of superficial residual tissue, Near complete clinical response |
| Short interval restagingClose 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 | Behavioural | Incomplete response with presence of superficial residual tissue, Near complete clinical response |
| Total mesorectal excisionThis technique consists of the surgical complete removal of the rectum, together with the surrounding mesorectum lymphovascular fatty tissue (mesorectum). | Procedure or surgery | Incomplete response with presence of superficial residual tissue, Near complete clinical response, No significant response |
Primary outcome
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
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.
Disease Recurrence
Time frame: From the endoscopic procedure date until 5 years after the completion of the neoadjuvant therapy
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic resection, Short interval restaging and Total mesorectal excision in people with Locally Advanced Rectal Cancer (LARC), run by Centre Hospitalier Universitaire Saint Pierre at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana Figueiredo (+32 23533332, mariana.figueiredo@stpierre-bru.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.