SBRT of Metastases Following Neo-adjuvant Treatment for Colorectal Cancer With Synchronous Liver Metastases
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAHS Cancer Control Alberta
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
stereotactic body radiation treatment (SBRT)
RadiationSBRT uses 3D imaging to target high doses of radiation to the affected area. There is very little damage to the surrounding healthy tissue. SBRT works by damaging the DNA of the targeted cells. Then, the affected cells can't reproduce, which causes tumors to shrink.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: SBRT to the metastatic liver +/- lung lesionsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression free survival (PFS)
Defined as Time from diagnosis to disease progression at any site or death
Time frame
From date of diagnosis upto 24 months in follow upSecondary outcomes
1
Quality of Life (QOL)C309v3
To study the Quality of Life as measured by QLQ (quality of life questionnaire)-C309v3)
Time frame
Baseline QOL will be assessed upto 24 months follow up2
Quality of Life (QOL)EORTC
To study the Quality of Life as measured by QLQ (quality of life questionnaire)- EORTC CR29 Questionnaire
Time frame
Baseline QOL will be assessed upto 24 months follow up3
Cancer Specific Survival (CSS)
Defined as the time from diagnosis to death due to the cancer
Time frame
Upto 24 months4
Overall Suvival(OS)
Defined as the time from diagnosis to death due to any cause .
Time frame
Expected to be within 3 months post treatmentOther outcomes
1
Exploratory endpoints/outcomes. To identify blood biomarkers that can correlate with disease events
Blood samples will be compared between the baseline and subsequent samples for changes in the expression levels of specific markers that may be associated with metastases and treatment response. These include circulating cell free DNA and exosomes. Carcino Embryonic Antigen (CEA) levels in blood will also be analysed. Micro Satellite Instability (MSI) pattern in the tumor tissue will be evaluated in the pathological tissue
Time frame
Blood samples will be collected at baseline upto 24 months in follow upSponsors and contacts
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Source ClinicalTrials.gov