Colorectal Cancer Trial, Recruiting NCT04050345 Sponsor: Royal Marsden NHS Foundation Trust Condition: Colorectal Cancer
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Colorectal Cancer Trial, Recruiting

NCT04050345
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:

Part B (before surgery):

  • People who have been newly diagnosed with colorectal cancer (confirmed by tissue testing) and are scheduled for surgery aimed at curing the cancer, with no signs of the cancer having spread to other parts of the body
  • People whose tissue testing shows high-grade abnormal cells and whose scans suggest colorectal cancer may be present — though continued participation after surgery depends on the cancer diagnosis being confirmed by the pathology results
  • People aged 18 or older
  • People who are able to understand and agree to take part in the study
  • People who are able to attend follow-up appointments as required

Part C (after surgery):

  • People aged 18 or older
  • People with confirmed high-risk stage II or stage III colon or rectal cancer who had surgery aimed at curing the cancer, with no signs of the cancer having spread — and who are planned to receive chemotherapy after surgery (specific staging and risk definitions should be confirmed with the trial site)
  • People whose surgery successfully removed the entire tumour with clear margins (more than 1mm of clear tissue around the tumour)
  • People whose blood counts and organ function meet the required levels for safe chemotherapy — including adequate white blood cell counts, platelet levels, haemoglobin, kidney function, and liver enzyme levels (confirm specific values with the trial site)
  • People who have not had major complications after surgery that would prevent them from receiving chemotherapy, in the opinion of the treating doctor
  • People who are assessed by an oncology team as suitable for chemotherapy, are able to have a blood sample collected after surgery, and can be enrolled within approximately 8–10 weeks after surgery
  • People with a general health/activity level rated as 0–2 on a standard medical scale (meaning able to carry out daily activities, with varying levels of limitation)
  • People who are able to understand and agree to take part in the study

Who may not be able to join:

Part B:

  • People who are planned to receive chemotherapy before surgery — although chemotherapy combined with radiation therapy before surgery is permitted for rectal cancer patients
  • People who have had another cancer diagnosis within the past 5 years — except for certain treated skin cancers, superficial bladder cancer, prostate pre-cancer, cervical carcinoma in situ, or other non-invasive cancers

Part C:

  • People who have had another cancer diagnosis within the past 5 years, except for non-melanoma skin cancers and carcinoma in situ
  • People who have had major complications after surgery, or other health conditions that the treating doctor considers would make chemotherapy unsafe
  • People who are not planned to receive chemotherapy after surgery
  • People who have a known allergy or medical reason preventing them from taking the planned chemotherapy drugs (capecitabine alone, or capecitabine combined with oxaliplatin)
  • People whose planned chemotherapy involves a drug called 5-Fluorouracil (5-FU), either alone or combined with oxaliplatin

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 28 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: David Cunningham, Royal Marsden NHS Foundation Trust

Phone: 02086426011

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
Royal Marsden NHS Foundation Trust
Registry
ClinicalTrials.gov
Start date
5 December 2016
Est. completion
31 July 2029

Where this trial is recruiting

🇬🇧 United Kingdom

Primary endpoints

TRACC Part B (Translational sub study); TRACC Part C (Randomised ctDNA guided adjuvant chemotherapy versus SoC study):

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: 28 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