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Radiation Therapy
SBRT for Colorectal Cancer Spread to Liver
Phase 2
Waitlist Available
Led By Aswin Abraham
Research Sponsored by AHS Cancer Control Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upto 24 months
Awards & highlights
Study Summary
This trial looks at using a type of radiation to treat colorectal cancer spread to the liver.
Who is the study for?
This trial is for adults with colorectal cancer that has spread to the liver. They must have 1-5 liver lesions, no larger than 5cm each, and be considered for curative SBRT by a tumor board. Candidates should not have had prior surgery or ablation for liver lesions, other metastases (except certain lung ones), or a recent history of another cancer.Check my eligibility
What is being tested?
The study is testing the use of stereotactic body radiation treatment (SBRT) on patients with colorectal cancer who have specific types of liver metastases. The goal is to see if this targeted radiation therapy can effectively treat these metastases after initial chemotherapy.See study design
What are the potential side effects?
While not explicitly listed in your information provided, common side effects from SBRT may include fatigue, skin reactions at the treatment site, nausea, and potential damage to nearby organs or tissues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ upto 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~upto 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival (PFS)
Secondary outcome measures
Cancer Specific Survival (CSS)
Overall Suvival(OS)
Quality of Life (QOL)C309v3
+2 moreOther outcome measures
Exploratory endpoints/outcomes. To identify blood biomarkers that can correlate with disease events
Trial Design
1Treatment groups
Experimental Treatment
Group I: SBRT to the metastatic liver +/- lung lesionsExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,188 Total Patients Enrolled
Aswin AbrahamPrincipal InvestigatorCross Cancer Institute, Alberta Health Services
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have liver and possibly treatable lung metastases.I have severe liver disease with cirrhosis.I have had surgery or ablation for liver lesions.My liver lesion was found soon after my cancer diagnosis and may be treated with targeted radiation.I am not a good fit for high-dose radiation treatment.My cancer has spread outside the liver, but lung spread might be operable.I cannot have surgery to remove part of my liver.I am 18 years old or older.I have 1-5 liver tumors, all in one lobe, and the largest is 5cm or smaller. A team of doctors believes they can be treated with targeted radiation.I can take care of myself and am up and about more than half of my waking hours.I have not had any cancer, except for basal cell carcinoma, in the last 5 years.I am scheduled for surgery to remove both my primary cancer and liver metastases.I had surgery to remove the primary cancer in my colon.I am scheduled for surgery to remove my cancer with the goal of curing it.
Research Study Groups:
This trial has the following groups:- Group 1: SBRT to the metastatic liver +/- lung lesions
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings for volunteers to join this clinical trial?
"Clinicaltrials.gov data reveals that recruitment for this trial, which was first posted on June 30th 2023 and last updated on March 7th 2023, is no longer active. Nevertheless, there are 1,631 other clinical trials currently welcoming participants."
Answered by AI
Has the FDA sanctioned Stereotactic Body Radiation Therapy for metastatic liver and/or lung lesions?
"Our team has tentatively assigned a score of 2 to the safety of stereotatic body radiation therapy for metastases in the liver and/or lungs, as this is only supported by initial clinical evidence."
Answered by AI
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