NCT05772923 Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision
| NCT ID | NCT05772923 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Netherlands Cancer Institute |
| Condition | Organ Preservation |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2021-04-16 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2021-04-16 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this prospective phase II feasibility study is to evaluate two additional local treatment options in rectal cancer patients with a good clinical response after neoadjuvant (chemo)radiation: contact x-ray brachytherapy versus extension of the waiting interval with or without local excision, and to investigate which rate of organ preservation can be achieved.
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;
Contact & Investigator
Brechtje A Grotenhuis, MD, PhD
PRINCIPAL INVESTIGATOR
Antoni van Leeuwenhoek Hospital
Frequently Asked Questions
Who can join the NCT05772923 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Organ Preservation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05772923 currently recruiting?
Yes, NCT05772923 is actively recruiting participants. Contact the research team at b.geubels@nki.nl for enrollment information.
Where is the NCT05772923 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Eindhoven, Netherlands, Amsterdam, Netherlands, Deventer, Netherlands and 3 additional locations.
Who is sponsoring the NCT05772923 clinical trial?
NCT05772923 is sponsored by The Netherlands Cancer Institute. The principal investigator is Brechtje A Grotenhuis, MD, PhD at Antoni van Leeuwenhoek Hospital. The trial plans to enroll 168 participants.