Recruiting nowPhase 3Randomised
| Registry number | NCT05673148 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 3 |
| Design | randomised, open label |
| Taking part | 364 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Alliance for Clinical Trials in Oncology |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Procedure Stereotactic Ablative Radiotherapy
- Procedure Resection
- Procedure Microwave Ablation
- Drug Chemotherapy
- Procedure Computed Tomography
- Procedure Magnetic Resonance Imaging
- Procedure Positron Emission Tomography
What it is measuring
Overall Survival (OS)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
What this trial is trying to do
The researchers expect that treating every known metastatic site with total ablative therapy—focused high-dose radiation, surgery, and/or heat-based microwave ablation—alongside usual drug treatment could control limited metastatic colorectal cancer better than drug treatment alone. The trial is testing this treatment strategy in people whose cancer has spread to no more than four body sites.
The comparison is usual systemic therapy alone versus systemic therapy plus local treatment intended to destroy all visible metastases. The main question is whether adding these procedures helps people live longer, measured by overall survival; the researchers also suggest it may remove or delay the return of treated tumours, but those are not the stated main outcome.
Worth knowing: Although these local treatments have been tested for safety, their benefit when added to systemic therapy in this setting has not been established.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
Phase 3. Compares the treatment against current standard care in a large group. This is the design that changes practice.
How the researchers describe it
This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Not yet treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
- PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma
- PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
- PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
- PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
- PRE-REGISTRATION (STEP 0): Primary tumor is already resected OR primary tumor is surgically amenable to resection, as determined by consultation and documentation with surgeon or documentation of discussion in the institutional multi-disciplinary tumor board where a surgeon confirms resectability. Patients with unresectable primary tumors are not eligible
- PRE-REGISTRATION (STEP 0): Four (4) or fewer apparent sites of metastatic disease based on review by local medical team of baseline radiographic imaging obtained prior to initiation of systemic therapy.
- Sites of metastatic disease must be radiographically evident, but pathologic confirmation is not required.
- Liver-only metastatic disease is NOT permitted.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 187 sites. Listed in: Canada, United States.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
The source
Registry record NCT05673148, registered by Alliance for Clinical Trials in Oncology on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.