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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.
This will be a phase II feasibility trial to evaluate ablative radiation for the management of colorectal cancer with potentially resectable/ablatabale synchronous oligo-metastases.
In this study, following completion of the neo-adjuvant component of treatment, patients will be re-staged (as is the current standard of care) and can then proceed for SBRT to the liver lesion. Patients who may have responded very well to the systemic treatment with no-residual disease on re-staging imaging, will use pre-treatment imaging for target delineation. The advantage of SBRT is in the minimally invasive approach to treatment that may be associated with lower morbidity, better quality of life and post treatment morbidity, as well as being significantly less expensive.
The planned course of the neo-adjuvant component of treatment for this study will reflect the NCCN (National Comprehensive Cancer Network) guidelines and will treat rectal cancer patients with a short course of radiation followed by 6-9 cycles of a combination chemotherapy regimen.
For the colon cancer group of patients, all patients will receive 6-9 cycles (2-3 months) of neo-adjuvant systemic chemotherapy as per current standard of care.
Patients with non-progressive disease at that point, will have SBRT for the metastatic lesion followed by surgery for the primary rectal cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT to the metastatic liver +/- lung lesions | Experimental | All rectal cancer patients included in the trial will receive short course radiation to the pelvis (with 25 Gy in 5 fractions) followed by chemotherapy with either 6 cycles of 3 weekly CAPOX chemotherapy or 9 cycles of 2 weekly FOLFOX. All colon cancer patients will receive 6 cycles of 3 weekly CAPOX or 9 cycles of 2 weekly FOLFOX. Patients will proceed for SBRT to the metastatic liver +/_ lung lesions and resection of the colorectal primary. Treatment planning is to be done using CT simulation or conventional simulation (Fluorocscopy) as per institutional practice. Simple beam arrangements, such as parallel opposed beams, are favored wherever possible. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic body radiation treatment (SBRT) | Radiation | SBRT 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | Defined as Time from diagnosis to disease progression at any site or death | From date of diagnosis upto 24 months in follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (QOL)C309v3 | To study the Quality of Life as measured by QLQ (quality of life questionnaire)-C309v3) | Baseline QOL will be assessed upto 24 months follow up |
| Quality of Life (QOL)EORTC |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aswin Abraham | Contact | 780-432-8516 | aswin.abraham@albertahealthservices.ca |
| Name | Affiliation | Role |
|---|---|---|
| Aswin Abraham | Cross Cancer Institute, Alberta Health Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cross Cancer Institute | Recruiting | Edmonton | Alberta | T6G 1Z2 | Canada |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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|
To study the Quality of Life as measured by QLQ (quality of life questionnaire)- EORTC CR29 Questionnaire
| Baseline QOL will be assessed upto 24 months follow up |
| Cancer Specific Survival (CSS) | Defined as the time from diagnosis to death due to the cancer | Upto 24 months |
| Overall Suvival(OS) | Defined as the time from diagnosis to death due to any cause . | Expected to be within 3 months post treatment |
| Toxicity Assessment | Treatment related toxicity will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5 | Toxicity assessment will be done upto 24 months in follow up |
| Blood samples will be collected at baseline upto 24 months in follow up |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |