Actively Recruiting
Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)
Led by Alexander Valdman · Updated on 2025-08-20
254
Participants Needed
9
Research Sites
358 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Preoperative Short-Course Radiation Therapy With PROtons Compared to Photons In High-Risk RECTal Cancer (PRORECT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven, newly diagnosed primary rectal adenocarcinoma with tumor less than 16 cm from anal verge
- Locally advanced tumor with at least one high-risk feature on pelvic MRI (clinical stage cT4a/b, extramural vascular invasion, N2-status, positive mesorectal fascia, or metastatic lateral nodes)
- Staging completed within 6 weeks before radiotherapy start
- No contraindications to CAPOX chemotherapy including adequate blood counts, renal clearance 6 ml/min, and bilirubin 5 bcmol/l
- Eastern Cooperative Oncology Group (ECOG) performance score 1
- Mentally and physically fit for CAPOX chemotherapy as judged by oncologist
- Age 18 years or older
- Written informed consent
- Adequate potential for follow-up
You will not qualify if you...
- Extensive tumor growth into upper sacrum (above S3) or lumbosacral nerve roots making surgery impossible
- Presence of metastatic disease or recurrent rectal tumor
- Familial Adenomatosis Polyposis coli (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC), active Crohn's disease or ulcerative colitis
- Concurrent malignancies except treated basocellular skin carcinoma or in situ cervical carcinoma; prior malignancies must be disease-free for at least 5 years
- Known dihydropyrimidine dehydrogenase (DPD) deficiency
- Contraindications to MRI (e.g., pacemaker)
- Medical or psychiatric conditions compromising informed consent
- Uncontrolled medical conditions
- Investigational rectal cancer treatments within past month
- Pregnancy or breastfeeding
- Known malabsorption syndromes or upper gastrointestinal tract physical integrity issues
- Active cardiac disease or myocardial infarction within past 12 months
- Symptoms of peripheral neuropathy
- Presence of pacemaker or implantable cardioverter defibrillator (ICD)
- Bilateral hip prostheses
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
Stockholm, Solna, Sweden, 17176
Actively Recruiting
2
Gävle Hospital
Gävle, Sweden
Actively Recruiting
3
Sahlgrenska University Hospital
Gothenburg, Sweden
Actively Recruiting
4
Linköping University Hospital
Linköping, Sweden
Actively Recruiting
5
Skåne University Hospital
Lund, Sweden
Actively Recruiting
6
Stockholm South General Hospital
Stockholm, Sweden
Actively Recruiting
7
Sundsvall Hospital
Sundsvall, Sweden
Actively Recruiting
8
University Hospital of Umeå
Umeå, Sweden
Actively Recruiting
9
Uppsala University Hospital
Uppsala, Sweden
Actively Recruiting
Research Team
A
Alexander Valdman, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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