NCT05772923Recruiting
Organ Preservation in Rectal Cancer: Contact X-ray Brachytherapy vs Extending the Waiting Interval and Local Excision
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
Source: ClinicalTrials.gov · Last updated 17 Mar 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 168 (estimated)
- First submitted
- 4 Mar 2021
- Start date
- 16 Apr 2021
- Primary completion date
- Mar 2025
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Colorectal cancer
- NCT number
- NCT05772923
What you commit to
- Study type: Interventional
- Planned participants: 168
- From 16 Apr 2021 to the primary completion date, Mar 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Antoni van Leeuwenhoek Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| IJsselland Hospital Coordinator of this site? Confirm its status | Capelle aan den IJssel | Netherlands | Recruiting |
| Deventer Hospital Coordinator of this site? Confirm its status | Deventer | Netherlands | Recruiting |
| Catharina hospital Coordinator of this site? Confirm its status | Eindhoven | Netherlands | Recruiting |
| Medical Center Leeuwarden Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Recruiting |
| Radbouw University Medical Centre Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Recruiting |
| Isala Coordinator of this site? Confirm its status | Zwolle | Netherlands | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.