Comparing two methods for preserving organs in rectal cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Brechtje A Grotenhuis, MD, PhD — Antoni van Leeuwenhoek Hospital
• Study coordinator: Barbara M Geubels, MD
• Email: b.geubels@nki.nl
• Phone: 0205129001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.