Short-Course Proton Radiation at a Higher Dose for Locally Advanced Rectal Cancer
Tests higher-dose short-course proton therapy in adults with locally advanced rectal cancer.
Plain-language title generated from the registry record
Registry title: Dose-Escalated Short-Course Proton Therapy for Locally Advanced Rectal Cancer
Key facts
- Where
- Aalborg, Aarhus, Copenhagen, Herlev, Næstved, Odense, and Vejle, DenmarkSee the 8 sites
Where in Denmark
- Aalborg University HospitalAalborg, DenmarkNo longer taking part
- Aarhus University HospitalAarhus, DenmarkNo longer taking part
- Danish Centre for Particle TherapyAarhus, DenmarkNo longer taking part
- RigshospitaletCopenhagen, DenmarkNo longer taking part
- Herlev HospitalHerlev, DenmarkNo longer taking part
- Zealand University Hospital, NaestvedNæstved, DenmarkNo longer taking part
- Odense University HospitalOdense, DenmarkNo longer taking part
- Vejle HospitalVejle, DenmarkNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT07903883
- Record updated
- 29 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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.
Exclusion: Previous pelvic radiotherapy; Implant, including an artificial hip, that precludes proton therapy; 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; 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.