Colorectal Cancer Trial, Recruiting NCT04525989 Sponsor: Alexander Valdman Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT04525989
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have been newly diagnosed with rectal cancer (confirmed by biopsy), where the lowest part of the tumour is within 16 cm of the opening of the back passage, measured using a special viewing instrument.
  • People whose cancer is locally advanced and shows at least one high-risk feature on a pelvic MRI scan, such as the tumour growing into a nearby organ or structure (for example, the prostate, bladder, uterus, tailbone, or pelvic wall), involvement of the lining of the abdominal cavity, cancer cells spreading into nearby blood vessels, a significant number of affected lymph nodes nearby, the tumour or lymph nodes being very close to or touching the surrounding tissue layer, or affected lymph nodes in the side walls of the pelvis.
  • People whose cancer staging was completed within 6 weeks before starting radiotherapy.
  • People whose blood test results show that the body is healthy enough to receive the chemotherapy combination used in this trial, including acceptable levels of white blood cells, platelets, haemoglobin, kidney function, and liver function (tested within 5 weeks before joining).
  • People who are in good enough general health to carry out daily activities with minimal limitation (confirm with trial site for exact fitness level required).
  • People who their oncologist considers mentally and physically fit enough to receive the chemotherapy used in this trial.
  • People aged 18 years or older.
  • People who are able to give written consent to participate.
  • People who are able to attend follow-up appointments as required.

Who may not be able to join:

  • People whose tumour has grown extensively into the upper part of the tailbone (above a certain level) or into nearby nerve roots, meaning surgery is considered impossible even if the tumour shrinks with treatment.
  • People whose cancer has spread to other parts of the body, or who have a recurrence of rectal cancer.
  • People with certain inherited bowel conditions (such as Familial Adenomatous Polyposis or Lynch Syndrome) or active inflammatory bowel disease (such as active Crohn's disease or active ulcerative colitis).
  • People who have, or have previously had, another cancer — unless it was a certain type of skin cancer or cervical cancer treated successfully, or unless the person has been cancer-free for at least 5 years.
  • People with a known deficiency of an enzyme called DPD, which affects how the body processes certain chemotherapy medicines.
  • People who cannot have an MRI scan, for example those with a pacemaker.
  • People with medical or mental health conditions that affect their ability to give informed consent.
  • People with other serious uncontrolled medical conditions.
  • People who have received any experimental treatment for rectal cancer in the past month.
  • People who are pregnant or breastfeeding.
  • People with conditions that affect the body's ability to absorb medicines through the digestive system, or who have significant problems with the upper digestive tract.
  • People with significant or active heart problems, such as heart failure, symptomatic coronary artery disease, irregular heart rhythm (including atrial fibrillation, even if managed with medication), or those who have had a heart attack within the past 12 months.
  • People who have symptoms of nerve damage in the hands or feet (peripheral neuropathy).
  • People who have a pacemaker or an implanted heart device (ICD).
  • People who have artificial hip replacements on both sides.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Alexander Valdman, MD, PhD, Department of Radiotherapy, Karolinska University Hospital, Stockholm, Sweden

Phone: +46(0)700021317

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Alexander Valdman
Registry
ClinicalTrials.gov
Start date
20 April 2021
Est. completion
1 March 2028

Where this trial is recruiting

🇸🇪 Sweden

Primary endpoints

Incidence of acute grade 2-5 gastrointestinal toxicity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov