Comparing proton and photon radiation therapy for high-risk rectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the potential benefits of using proton beam radiation therapy compared to conventional photon beam radiation therapy in patients with locally advanced rectal cancer. The focus is on assessing whether proton therapy can reduce acute gastrointestinal toxicity, thereby improving patient tolerability to subsequent chemotherapy. Patients will receive a short course of radiation followed by chemotherapy and surgery, with the trial initially conducted at select centers and later expanded to others in the Skandion network. The study aims to provide insights into the effectiveness and safety of proton therapy in this patient population.

Why it matters

Who can join: the full rules

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

Where it's running

• Karolinska University Hospital, Theme Cancer, Dept of Pelvic cancer
  Stockholm, Solna, Sweden Recruiting
• Gävle Hospital
  Gävle, Sweden Recruiting
• Sahlgrenska University Hospital
  Gothenburg, Sweden Recruiting
• Linköping University Hospital
  Linköping, Sweden Recruiting
• Skåne University Hospital
  Lund, Sweden Recruiting
• Stockholm South General Hospital
  Stockholm, Sweden Recruiting

Study contacts

• Principal investigator: Alexander Valdman, MD, PhD — Department of Radiotherapy, Karolinska University Hospital, Stockholm, Sweden
• Study coordinator: Alexander Valdman, MD, PhD
• Email: alexander.valdman@regionstockholm.se
• Phone: +46(0)700021317

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Active surveillance vs chemoradiotherapy after local removal of intermediate-risk T1 rectal cancer

  This study tests whether close follow-up alone after local removal of early rectal cancer can match the cancer control of adding chemoradiotherapy, while reducing treatment-related side effects.

  Recruiting at 2 sites Medical University of Gdansk · Limoges and 2 other locations · NCT07669298

• Different-Dose Short-Course Radiotherapy With CAPOX, PD-1 Blockade, and IL-2 in Locally Advanced Rectal Cancer

  This phase II trial tests whether a low-dose short-course radiotherapy combined with CAPOX, a PD-1 blocker, and IL-2 works as well as the standard-dose short-course approach in patients with locally advanced rectal cancer.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07646639

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.