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New treatment option for Colorectal Cancer
Official title SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
ClinicalTrials.gov ID: NCT05775146
What this study is testing
- What it's testing
- The purpose of this study is to prospectively evaluate the feasibility of SBRT for the management of synchronous oligo metastatic liver metastases from colorectal cancers.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) 0-2
- Able to provide written informed consent
- 1-5 Liver lesions with max size of ≤5cm for a single lesion and restricted to one lobe of liver; deemed at Multi-Disciplinary Tumor Board (MDT) to be...
- Liver lesion identified within 3 months of diagnosis of primary and deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for...
You likely can't join if
- Extra-hepatic metastases (except potentially resectable lung mets)
- Not a suitable candidate for liver resection surgery
- Not a suitable candidate for SBRT
- Past history of cancer within 5 years (except basal cell carcinoma)
- Patients who have undergone previous surgery or ablation for liver lesions
- Planned simultaneous resection of primary and liver metastases
See the full eligibility criteria
- Age ≥ 18 years
- ECOG (Eastern Cooperative Oncology Group) 0-2
- Able to provide written informed consent
- 1-5 Liver lesions with max size of ≤5cm for a single lesion and restricted to one lobe of liver; deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent
- Liver lesion identified within 3 months of diagnosis of primary and deemed at Multi-Disciplinary Tumor Board (MDT) to be potentially amenable for SBRT with curative intent
- Plan for resection of primary with curative intent
- Patients with liver metastases and potentially resectable/ablatable lung mets can be included.
- Colon cancer patients who have undergone upfront resection of primary colonic lesion can be included
- Able and willing to comply with the terms of the protocol including health-related quality of life (HRQoL) questionnaires
- Women of child bearing potential (WOCBP) must have a negative serum (or urine) pregnancy test at the time of screening. WOCBP is defined as any female who has experienced menarche and who has not undergone surgical...
- Females must not be breastfeeding
- Male patients should agree to not donate sperm during the study
- Extra-hepatic metastases (except potentially resectable lung mets)
- Not a suitable candidate for liver resection surgery
- Not a suitable candidate for SBRT
- Past history of cancer within 5 years (except basal cell carcinoma)
- Patients who have undergone previous surgery or ablation for liver lesions
- Planned simultaneous resection of primary and liver metastases
- Pregnancy
- Patients with Child-Pugh C and documented cirrhosis
The study team makes the final eligibility decision.
Where it's taking place
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edmonton, Alberta, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.