Comparing proton and standard radiation before surgery for rectal cancer
Compares proton radiation with standard radiation before surgery in adults with high-risk rectal cancer.
Plain-language title generated from the registry record
Registry title: Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)
Key facts
- Where
- Gävle, Gothenburg, Linköping, Lund, Stockholm, Sundsvall, Umeå, and Uppsala, SwedenSee the 9 sites
Where in Sweden
- Gävle HospitalGävle, SwedenTaking people
- Sahlgrenska University HospitalGothenburg, SwedenTaking people
- Linkoping University HospitalLinköping, SwedenTaking people
- Skåne University HospitalLund, SwedenTaking people
- Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancerStockholm, SwedenTaking people
- Stockholm South General HospitalStockholm, SwedenTaking people
- Sundsvall HospitalSundsvall, SwedenTaking people
- University Hospital of UmeåUmeå, SwedenTaking people
- Uppsala University HospitalUppsala, SwedenTaking people
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
- Alexander Valdman
- Trial code
- NCT04525989
- Record updated
- 10 August 2026
- Original description
To investigate a potential toxicity benefit of preoperative radiation therapy with protons compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer.Read full original descriptionShow less
Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT): A Prospective Randomized Swedish Phase II Trial
To investigate a potential toxicity benefit of preoperative radiation therapy with protons compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer.
Inclusion: Biopsy-proven, newly diagnosed primary rectal adenocarcinoma, i.e. with the lowest part of the tumour less than 16 cm from the anal verge detected using a rigid rectoscope; Locally advanced tumour fulfilling at least one of the following criteria on pelvic MRI indicating high risk of failing locally and/or systemically:; Clinical stage (c) T4b, i.e. infiltration of an adjacent organ or structure like the prostate, urinary bladder, uterus, sacrum, pelvic floor or side-wall (according to TNM version 8); cT4a, i.e. peritoneal involvement; Extramural vascular invasion (EMVI+); N2-status regarded as metastatic according to ESGAR consensus criteria; Positive MRF, i.e. tumor or lymph node one mm or less from the mesorectal fascia; Metastatic lateral nodes (lat LN+) according to ESGAR consensus criteria; Staging done within 6 weeks before start of radiotherapy. No contraindications to chemotherapy with CAPOX including adequate blood counts, (within 5 weeks prior to randomisation):; white blood count ≥4.0 x 10*9/L; platelet count ≥100 x 10*9/L; clinically acceptable haemoglobin levels; creatinine levels indicating renal clearance of ≥50 ml/min; bilirubin ˂35 µmol/l; ECOG performance score ≤1; Patient is considered to be mentally and physically fit for chemotherapy with CAPOX as judged by the oncologist; Age ≥18 years; Written informed consent; Adequate potential for follow-up.
Exclusion: Extensive growth into cranial part of the sacrum (above S3) or the lumbosacral nerve roots indicating that surgery will never be possible even if substantial tumour down-sizing is seen; Concurrent uncontrolled medical conditions; Presence of metastatic disease or recurrent rectal tumour. Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or active ulcerative Colitis; Concomitant malignancies, except for adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri. Subjects with prior malignancies must be disease-free for at least 5 years; Medical or psychiatric conditions that compromise the patient's ability to give informed consent; Any investigational treatment for rectal cancer within the past month; Patients with known malabsorption syndromes or a lack of physical integrity of the upper gastrointestinal tract; Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac dysrhythmia, e.g. atrial fibrillation, even if controlled with medication) or myocardial infarction within the past 12 months; Known DPD deficiency; Any contraindications to MRI (e.g. patients with pacemakers); Pregnancy or breast feeding; Patients with symptoms of peripheral neuropathy; Patients with pacemaker or ICD; Patients with bilateral hip protheses.