Can precision protons spare rectal cancer patients from harsh side effects?
NCT ID NCT04525989
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This trial is testing whether proton beam radiation, a more precise form of radiation, causes fewer stomach and bowel side effects than standard photon radiation when given before surgery for high-risk rectal cancer. About 254 patients will be randomly assigned to receive either protons or photons as a short course of radiation. The goal is to see if protons can reduce acute gastrointestinal toxicity while still effectively treating the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton beam radiation therapy compared to conventional photon radiation therapy
- What this could lead to
- If protons cause fewer gastrointestinal side effects than photons, this could establish a new standard for pre-surgery radiation in rectal cancer, improving patients' quality of life during treatment.
- What could go wrong
- This is a phase II trial, so results are preliminary. Protons may not show a significant toxicity benefit, and there could be unforeseen side effects or logistical challenges in delivering proton therapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 254 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Inclusion Criteria - Primary tumour characteristics * 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 Inclusion Criteria - General * 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 Criteria: * 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. * 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. * Known DPD deficiency. * Any contraindications to MRI (e.g. patients with pacemakers). * Medical or psychiatric conditions that compromise the patient's ability to give informed consent. * Concurrent uncontrolled medical conditions. * Any investigational treatment for rectal cancer within the past month. * Pregnancy or breast feeding. * 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. * Patients with symptoms of peripheral neuropathy. * Patients with pacemaker or ICD * Patients with bilateral hip protheses
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gävle Hospital
RECRUITINGGävle, Sweden
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Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
RECRUITINGStockholm, Solna, 17176, Sweden
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Linköping University Hospital
RECRUITINGLinköping, Sweden
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Sahlgrenska University Hospital
RECRUITINGGothenburg, Sweden
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Skåne University Hospital
RECRUITINGLund, Sweden
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Stockholm South General Hospital
RECRUITINGStockholm, Sweden
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Sundsvall Hospital
RECRUITINGSundsvall, Sweden
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University Hospital of Umeå
RECRUITINGUmeå, Sweden
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Uppsala University Hospital
RECRUITINGUppsala, Sweden
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