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Standard vs Targeted Radiation Therapy for Liver Cancer (SAVIOR Trial)
SAVIOR Trial Summary
This trial is comparing two different types of radiation therapy for people with liver cancer. Standard radiation therapy is when doctors use lower doses of radiation to try and kill the cancer cells. The second type is called SBRT, which is when doctors use higher doses of radiation and try to target the cancer cells more specifically. The trial is testing to see if SBRT is more effective in treating liver cancer and if it has less side effects than standard radiation therapy.
SAVIOR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSAVIOR Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2013 Phase 3 trial • 397 Patients • NCT00004054SAVIOR Trial Design
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- My condition cannot be treated with surgery.My liver condition is not severe (Child Pugh ≤B7).I stopped taking multikinase inhibitors 2 weeks before radiation and can restart 1 week after.I am older than 18 years.My life expectancy is more than 6 months despite my other health issues.My liver cancer or liver metastases is 25 cm or smaller.I have received treatments like immunotherapy or drugs targeting multiple kinases.My liver or bile duct cancer is confirmed by lab tests.I have had surgery or treatment to remove or destroy liver tissue.I've had radiation in the same area where my current cancer is located.My liver cancer spread is confirmed and not lymphoma.I do not have active hepatitis or severe liver problems, or my hepatitis is treated.I have cancer that has spread to my liver, confirmed by scans.I am not pregnant, nursing, or able to become pregnant and will use contraception during the study.I can safely undergo radiotherapy.I have liver cancer with specific blood test results and liver condition.I have 5 or fewer liver tumors visible on a recent scan.I finished chemotherapy at least 2 weeks ago and won't start again for at least 1 week after radiation.My liver cancer is considered life-limiting despite having cancer elsewhere.I can take care of myself but may not be able to do heavy physical work.You are expected to live for at least 6 more months.
- Group 1: Personalized Dose Selection Radiation
- Group 2: Standard Dose Radiation
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What goals have been set for this medical investigation?
"This medical study will observe the overall survival of participants over a 6-month period. Secondary outcomes to be measured include Quality of Life (QOL) using a validated instrument, comprising physical, social/family, and functional well being metrics; FACT-Hepatobiliary questionnaire scores which range from 0 - 180 points with lower scores indicating better health; NCI-CTCAE 5.0 Score System toxicity grades ranging between 1-5; and extrahepatic failure determined by any new lesions outside of the liver organ."
Is it possible to sign up as a participant in this clinical trial at the present moment?
"The available data on clinicaltrials.gov confirms that this trial is presently recruiting patients, having been posted initially on August 1st 2021 and last updated November 8th 2022."
How many individuals are currently receiving treatment from this clinical experiment?
"Affirmative. Per the information on clinicaltrials.gov, this medical trial is still recruiting patients since it was first published in August of 2021 and last updated November 8th 2022. 110 participants are intended to be recruited from a single site."
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