Comparing two methods for preserving organs in rectal cancer patients

Organ Preservation in Patients With a Good Clinical Response After (Chemo)Radiation for Rectal Cancer: Defining the Role of Additional Contact X-ray Brachytherapy Versus Extending the Waiting Interval and Local Excision

This study is testing two different ways to treat rectal cancer in patients who responded well to initial treatment, to see which method helps them keep their organs and improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Netherlands Cancer Institute (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 7 sites (Nijmegen, Gelderland and 6 other locations)
• Trial ID: NCT05772923 on ClinicalTrials.gov

What this trial studies

This prospective phase II feasibility study evaluates two local treatment options for rectal cancer patients who have shown a good clinical response after neoadjuvant (chemo)radiation. The study compares contact x-ray brachytherapy with an extended waiting interval and local excision to determine which method achieves better rates of organ preservation. The rationale is to improve patients' quality of life by avoiding total mesorectal excision surgery. The study aims to optimize treatment strategies based on the extent of clinical response monitored through radiological and endoscopic assessments.

Who should consider this trial

Good fit: Ideal candidates include patients with histologically verified adenocarcinoma located above the dentate line and within 10cm of the anal verge, who have had a good clinical response after neoadjuvant (chemo)radiation.

Not a fit: Patients with significant distant metastases or those who do not meet the specific clinical response criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved organ preservation and quality of life for rectal cancer patients.

How similar studies have performed: Other studies have explored organ preservation in rectal cancer, but this specific comparison of treatment options is novel.

Eligibility criteria

Inclusion Criteria:

* histologically verified adenocarcinoma above the dentate line and within 10cm of the anal verge;
* neoadjuvant short-course radiotherapy for patients with 1) IRC and delayed response evaluation according to the Dutch national guidelines (cT1-3, cN1-2 lymph nodal status, no involved MRF or cT3c-d, N0-1 lymph nodal status without pres-ence of significant distant metastases) without full dose chemotherapy in the inter-val (e.g. Rapido-scheme) or 2) LARC due to comorbidity or frailty; OR
* neoadjuvant long-course radiotherapy (chemoradiation) for patients with 1) LARC according to the Dutch national guidelines (cT4 tumour, cN2 lymph nodal status, lateral lymph node involvement, and/or involved MRF, without the presence of significant distant metastases) or 2) early rectal cancer or IRC and a strong wish for organ preservation;
* clinically near-complete response or a small residual tumour mass \<3 cm;
* technically feasible to perform both treatment options (contact x-ray brachytherapy or local excision);
* age \>18 years;
* written informed consent.

Exclusion Criteria:

* neoadjuvant or induction chemotherapy prior or adjacent to (chemo)radiation, e.g. patients with a Rapido or M1-scheme are not eligible;
* radiation dose \>50.4 Gy or boost dose on the primary tumour;
* presence of suspicious lymph nodes (yN1/N2) at first response evaluation;
* residual tumour ≥ 3cm or over half of the circumference of the rectal lumen;
* patients who are unable to undergo contact x-ray brachytherapy or local excision;
* patients who cannot tolerate a completion- or salvage-TME because of comorbidity or frailty;

Where this trial is running

Nijmegen, Gelderland and 6 other locations

• Radbouw University Medical Centre — Nijmegen, Gelderland, Netherlands (Recruiting)
• Catharina Hospital — Eindhoven, North Brabant, Netherlands (Recruiting)
• Antoni van Leeuwenhoek — Amsterdam, North Holland, Netherlands (Recruiting)
• Deventer Hospital — Deventer, Overijssel, Netherlands (Recruiting)
• Isala — Zwolle, Overijssel, Netherlands (Recruiting)
• Medical Center Leeuwarden — Leeuwarden, Provincie Friesland, Netherlands (Recruiting)
• Ijsselland Hospital — Capelle aan den IJssel, South Holland, Netherlands (Recruiting)

Study contacts

• Principal investigator: Brechtje A Grotenhuis, MD, PhD — Antoni van Leeuwenhoek Hospital
• Study coordinator: Barbara M Geubels, MD

Conditions Organ Preservation; Rectal Cancer; Quality of Life; Locally Advanced Rectal Carcinoma; Organ preservation; Rectal cancer; radiation; Local excision