NCT07903883Not yet recruiting
Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Feasibility of Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer: A National Multicentre Feasibility Study to Prepare a Phase III Randomised Trial
Source: ClinicalTrials.gov · Last updated 29 Oct 2026
Brief summary (registry, in English)
This prospective national multicentre feasibility study evaluates dose-escalated short-course proton radiotherapy followed by total neoadjuvant chemotherapy in patients with primary high-risk locally advanced rectal adenocarcinoma. The study will assess willingness to participate and travel for proton therapy, completion of planned treatment, early clinical complete response, safety, patient-reported outcomes, and feasibility of circulating cell-free and tumour DNA sampling. Patients with a clinical complete response may enter a watch-and-wait programme; other patients will undergo surgery according to national guidelines.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 22 Oct 2026
- Start date
- Nov 2026
- Primary completion date
- Nov 2029
- Lead sponsor
- University of Aarhus
- Diseases
- Colorectal cancer
- NCT number
- NCT07903883
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Nov 2026 to the primary completion date, Nov 2029
- 8 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
- Previous pelvic radiotherapy.
- Implant, including an artificial hip, that precludes proton therapy.
Other illness
- Distant metastatic disease at baseline (M1).
- Recurrent rectal cancer.
- Serious comorbidity or other condition making total neoadjuvant therapy unsafe in the investigator's judgement.
- Contraindication to MRI, including an incompatible cardiac implantable electronic device.
Other
- Rectal tumour invading cranial sacral bone or lumbosacral nerve roots.
- Mismatch repair-deficient or microsatellite instability-high tumour.
- Pregnancy or breastfeeding.
- Inability to comply with study procedures or follow-up.
Who the study is looking for
- Age 18 years or older.
- Eastern Cooperative Oncology Group performance status 0-1.
- Fit for combination chemotherapy.
- Biopsy-verified primary locally advanced rectal adenocarcinoma.
- At least one high-risk feature: cT3c, cT4a, or cT4b disease; tumour or lymph node 1 mm or less from the mesorectal fascia; enlarged lateral pelvic lymph nodes; or extramural vascular invasion on MRI.
- Laboratory values adequate for chemotherapy according to local guidelines.
- Able to understand the study information and provide written informed consent.
- Willing to receive dose-escalated short-course proton radiotherapy.
- Willing and able to travel to the Danish Centre for Particle Therapy for planning and treatment.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Unknown status |
| Danish Centre for Particle Therapy Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Herlev Hospital Coordinator of this site? Confirm its status | Herlev | Denmark | Unknown status |
| Zealand University Hospital, Naestved Coordinator of this site? Confirm its status | Næstved | Denmark | Unknown status |
| Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
| Vejle Hospital Coordinator of this site? Confirm its status | Vejle | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.