Optimizing patient selection for surgery in advanced rectal cancer
Role of Local Endoscopic Excision After Neoadjuvant Therapy in Locally Advanced Rectal Cancer: A Prospective Study
NA · Centre Hospitalier Universitaire Saint Pierre · NCT06761287
This study is testing if a new way to remove leftover cancer tissue after treatment can help doctors choose the best surgery for patients with advanced rectal cancer who responded well to earlier therapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Saint Pierre (other) |
| Locations | 1 site (Brussels) |
| Trial ID | NCT06761287 on ClinicalTrials.gov |
What this trial studies
This interventional trial evaluates the effectiveness of endoscopic resection following neoadjuvant therapy in patients with locally advanced rectal cancer. The study is divided into two phases: the first phase assesses the feasibility and safety of endoscopic resection of residual tissue, while the second phase aims to determine how this approach can guide patient selection for total mesorectal excision or serve as a definitive treatment for those with limited residual disease. The trial focuses on patients who have shown a complete or near-complete response to neoadjuvant therapy.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with locally advanced rectal cancer who have shown a complete or near-complete response to neoadjuvant therapy.
Not a fit: Patients with a history of rectal cancer or previous rectal surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and reduce the need for extensive surgery in patients with locally advanced rectal cancer.
How similar studies have performed: Other studies have shown promise in using endoscopic techniques for similar conditions, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brussels
- CHU Saint Pierre — Brussels, Belgium (RECRUITING)
Study contacts
- Study coordinator: Mariana Figueiredo
- Email: mariana.figueiredo@stpierre-bru.be
- Phone: +32 23533332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Locally Advanced Rectal Cancer, locally advanced rectal cancer, neoadjuvant, endoscopic resection, endoscopic submucosal dissection, endoscopic intermuscular dissection, feasibility, safety