Phase 3 Colorectal Cancer Trial, Recruiting NCT05673148 Sponsor: Alliance for Clinical Trials in Oncology Condition: Colorectal Cancer
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Phase 3 Colorectal Cancer Trial, Recruiting

NCT05673148
Recruiting Phase 3

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 diagnosed with colorectal cancer that has spread to other parts of the body (metastatic), confirmed by a tissue sample.
  • People whose cancer does not have a specific genetic marker called microsatellite instability (MSI) (confirm with trial site).
  • People whose cancer does not have a specific gene change called a BRAF V600E mutation.
  • People who have had brain metastases that were treated, provided that follow-up brain scans show the cancer has not grown or spread further in the brain.
  • People who have no signs of cancer spread to the lining of the abdomen (peritoneum) or surrounding fatty tissue (omentum); if scans suggest this may be present, a keyhole surgical procedure may be needed to confirm its absence.
  • People whose original bowel tumour has already been surgically removed, or where a surgeon has confirmed it can be removed.
  • People who have four or fewer separate sites where cancer has spread, based on imaging scans taken before chemotherapy started — not including cases where the cancer has spread only to the liver (at least one other site outside the liver must also be present).
  • People whose spread sites can be treated using some combination of surgery, microwave ablation, or a precise form of targeted radiation called SABR, with at least one site suitable for SABR — a radiation specialist must confirm this.
  • People whose cancer can be measured on scans according to standard criteria (RECIST v1.1).
  • People who have received no more than 16 weeks (4 months) of chemotherapy or systemic treatment before the first stage of enrolment.
  • People who have received between 16 and 24 weeks (4 to 6 months) of first-line systemic treatment for their metastatic cancer at the time of full registration.
  • People whose cancer has shown no clear signs of getting worse during systemic treatment.
  • People who are not considered suitable for a specific liver-directed pump treatment (hepatic artery infusion pump therapy), or where the benefit of that treatment is unclear.
  • People who completed any earlier cancer treatment (such as adjuvant chemotherapy after surgery) at least 12 months before the metastatic cancer was diagnosed.
  • People aged 18 or older.
  • People who are well enough to carry out basic daily activities, based on a standard medical scoring scale (ECOG performance status of 0 to 2).
  • People with adequate blood counts, kidney function, and liver function as measured by specific blood tests (confirm with trial site for exact values).
  • People living with HIV who are on effective HIV treatment and have had an undetectable viral load within the past 6 months.
  • Women of childbearing potential must have a negative pregnancy test within 14 days before registration, as the treatments involved carry known risks to a developing baby.
  • People who are not pregnant and not breastfeeding.
  • People who are not planning to take part in any other clinical trial at the same time.

Who may not be able to join:

  • No specific exclusion criteria were listed for this trial (confirm with trial site).

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 21 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 614-685-4922

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
Phase 3
Registry
ClinicalTrials.gov
Start date
9 October 2023
Est. completion
3 July 2028

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Overall Survival (OS)

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: 21 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