Hepatocellular Carcinoma Clinical Trial
— SAVIOROfficial title:
A Phase III Randomized Trial of Standard Dose Stereotactic Body Radiation Therapy (SBRT) Versus Radiobiologically-Guided Dose Selected SBRT In Primary or Secondary Liver Carcinoma (SAVIOR).
NCT number | NCT04745390 |
Other study ID # | SAVIOR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | August 1, 2021 |
Est. completion date | April 2027 |
Radiation is a standard treatment option for patients with liver cancer. Unfortunately, the tumour grows after radiation in many patients and radiation can harm normal tissues. A new treatment using a specialized radiation procedure called Stereotactic body radiotherapy (SBRT) may increase the chance to control liver cancer and reduce the chance of harm to normal tissues. SBRT allows radiation treatments to be focused more precisely, and be delivered more accurately than with older treatments. SBRT has become a routine treatment. Further research has found that specialized computer programs can possibly guide the selection of an appropriate SBRT dose. This is called radiobiological guidance. However, this has not yet been proven to improve outcomes and/or reduce toxicity. Therefore, the purpose of this study is to find out if SBRT at standard dose versus SBRT guided by radiobiological techniques is better for you and your liver cancer.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | April 2027 |
Est. primary completion date | April 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Eligible patients include patients with any of the following: - Primary hepatobiliary cancer confirmed pathologically or, - Non-lymphoma liver metastases confirmed pathologically or, - Radiographic liver lesions most consistent with metastases, in a patient with known pathologically proven non-lymphoma cancer and a previously negative CT or MRI of the liver or, - Hepatocellular carcinoma diagnosed with vascular enhancement of the lesion consistent with hepatocellular carcinoma, and with an elevated AFP, in the setting of cirrhosis or chronic hepatitis. 2. = 5 liver lesions measurable on a contrast-enhanced liver CT or MRI performed within 90 days prior to study entry. 3. Primary liver lesion or liver metastases measuring = 25 cm. 4. Extrahepatic cancer is permitted if liver involvement is judged to be life-limiting 5. No contraindications to radiotherapy 6. Patient must be judged medically or surgically unresectable 7. Zubrod Performance Scale = 0-3 8. Age > 18 9. Systemic treatment including multikinase inhibitors and immunotherapy are allowed. Multikinase inhibitors must be held 2 weeks prior to radiation and may be restarted 1 week post radiation. 10. Previous liver resection or ablative therapy is permitted 11. Chemotherapy must be completed at least 2 weeks prior to radiation therapy and not planned to be administered for at least 1 week (for anthracyclines at least 4 weeks) after completion of treatment. 12. Life expectancy > 6 months. 13. Women of childbearing potential and male participants must practice adequate contraception. Exclusion Criteria: 1. Severe cirrhosis or liver failure defined as Child Pugh >B7 2. Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields 3. Severe, active co-morbidity, defined as limiting the patient's life to less than 6 months 4. Active hepatitis or clinically significant liver failure. Treated hepatitis is permitted. 5. Pregnancy, nursing women, or women of childbearing potential, and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be teratogenic. |
Country | Name | City | State |
---|---|---|---|
Canada | London Regional Cancer Program | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall survival | What will be overall survival of patients in two arms? How many patients progressed in each arm after receiving radiation? | 6 months | |
Primary | Treated lesion progression | What is the local radiated lesion progression rate? | 6 months | |
Secondary | Response rate - Modified RECIST criteria | To calculate the response rate for each patient according to the modified RECIST criteria.
Complete Response: Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease: At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started |
6 months | |
Secondary | Extrahepatic failure | Number of patients presented with Extrahepatic failure which defined by Any new lesion present outside of the liver organ. | From date of randomization until the date of first documented extrahepatic failure or date of death from any cause, whichever came first, assessed up to 2 years | |
Secondary | Time to intrahepatic progression | To calculate the time in months or years for cancer recurrence after treatment. | From date of randomization until the date of first documented intrahepatic progression or date of death from any cause, whichever came first, assessed up to 2 years | |
Secondary | Toxicity from the intervention | Evaluate acute and long-term G3 or larger toxicity based on NCI-CTCAE 5.0 score system. Grade 1 to Grade 5. Higher the grade more severe is the toxicity. | 6 months | |
Secondary | Comparison of Quality of Life (QOL) Using a Standardly-Used Validated Instrument. Specifically, measures of physical, social/family, and functional well being. Overall symptoms, function, global health status will also be compared. | EORTC QLQ-C30(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) comprises 5 functional, 3 symptom, 6 single symptom and 1 global health status scale. A higher score denotes a better quality of life for the function and global health scales. A lower score on the symptom and single item scales indicates a lower state of the patient. Overall score will be the primary measure. Scale is 0-100 points. | Pre-treatment, weekly during treatment, 1 month post treatment, 3 month post treatment, every 3 months up to 5 years. | |
Secondary | Comparison of Quality of Life (QOL) Using a Standardly-Used Validated Instrument. Specifically, measures of physical, social/family, and functional well being. Overall symptoms, function, global health status will also be compared. | FACT-Hep(Functional Assessment of Cancer Therapy-Hepatobiliary questionnaire) is a specific to liver patient quality of life instrument assessing the functional quality of life of patients with hepatobiliary cancer. It has 45 Likert-type items with well-being domains of physical, social/family, emotional, functional plus a hepatobiliary cancer subscale. Aggregate overall lower scores denote a better state of the patient (leading some items to be reverse scored). Overall score will be the primary measure. Scale is 0-180 points. | Pre-treatment, weekly during treatment, 1 month post treatment, 3 month post treatment, every 3 months up to 5 years. |
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