Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can precision protons spare rectal cancer patients from harsh side effects?

NCT ID NCT04525989

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 254 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Locally advanced rectal adenocarcinoma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Gävle Hospital

    RECRUITING

    Gävle, Sweden

  • Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer

    RECRUITING

    Stockholm, Solna, 17176, Sweden

  • Linköping University Hospital

    RECRUITING

    Linköping, Sweden

  • Sahlgrenska University Hospital

    RECRUITING

    Gothenburg, Sweden

  • Skåne University Hospital

    RECRUITING

    Lund, Sweden

  • Stockholm South General Hospital

    RECRUITING

    Stockholm, Sweden

  • Sundsvall Hospital

    RECRUITING

    Sundsvall, Sweden

  • University Hospital of Umeå

    RECRUITING

    Umeå, Sweden

  • Uppsala University Hospital

    RECRUITING

    Uppsala, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.