Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Li… (NCT01528878) | Clinical Trial Compass
CompletedNot Applicable
Safety, Efficacy, and Dosing of Stereotactic Radiosurgery for Hepato-cellular Carc/Colo-rectal Liver Metastases
United States30 participantsStarted 2009-04
Plain-language summary
The purpose of this study is to determine a tolerable dose of radiation delivered by the CyberKnife system in two groups of patients with hepatocellular carcinoma (HCC).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Hepatocellular carcinoma (as defined by biopsy or alpha-fetoprotein (AFP) greater than 1000ng/dL with appropriate imaging) or liver metastases from colorectal cancer or other tumor (as defined by biopsy or elevated Carcinoembryonic antigen (CEA) or a positive positron emission tomography (PET) scan in conjunction with a mass on CT or MRI in a patient with previously resected cancer). Patients with at least one measurable liver lesion and no more than 3 are eligible if they meet all other eligibility criteria including the dose constraints on the composite plan.
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
. Patients are not candidates for definitive surgical resection because of tumor location, hepatic function, or other medical or personal reasons.
. Patients with HCC who are being considered for liver transplant may be entered as a bridge to transplant if it is considered by the transplant team that an ablative therapy would be of value while awaiting transplant.
. If cirrhosis is present, patients will have Child-Pugh score of A or B (see Appendix A in the Master Protocol).
. Patients will have tumors not optimally treated with radio-frequency ablation by interventional radiology, or by GI/transplant surgery. This could be for reasons of size, tumor location, or other reasons.
. Ability to place fiducial markers in the vicinity of the tumor to allow for radiographic tracking of respiratory motion and tumor localization. Fiducial placement will generally be done by interventional radiology.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Tolerability of Stereotactic Body Radiotherapy (SBRT) Based on Number of Cumulative Acute Toxicities Occurring Within 90 Days of Treatment and Related to SBRT.
. Estimates of hepatic tolerance must meet the criteria as defined in Section III. This eligibility will not be able to made definitively until the patient has agreed to participate. in the study and the appropriate scan analyses and dosimetry have been performed. No more than one decrement in dose from the planned dose level will be allowed for an individual patient because of exceeding the maximal liver doses before the patient is declared ineligible for study.
Exclusion criteria
. Child-Pugh Class C cirrhosis
. Patients with clinically apparent central nervous system (CNS) disease.
. Medical or psychiatric illness that would not allow the patient to tolerate the proposed treatment including inability to lie flat for an extended period of time, severe claustrophobia or other reasons.
. Uncontrolled or significant cardiovascular disease including: myocardial infarction within 6 months, uncontrolled angina within 6 months, Class III-IV New York Heart Association (NYHA) congestive heart failure, grade 3 cardiac valve dysfunction
. Evidence of decompensated liver disease as evidenced by: clinically significant ascites refractory to diuretic therapy) evidence of hepatic encephalopathy, coagulopathy not corrected by conservative measures.
. A history of CTCAE Grade 3 bleeding esophageal or gastric varices within the past 2 months. Prior variceal bleed permitted if patient has undergone banding or sclerotherapy and there has been no evidence of bleeding for 2 months. Patients at risk for varices (based on the following: known history of esophageal or gastric varices; evidence of hepatic cirrhosis and/or portal hypertension including biopsy-proven cirrhosis, hypersplenism, or radiographic findings of varices) will be screened for esophageal varices. If varices are identified that require intervention (banding), patient will not be eligible until varices adequately treated.
. Prisoners or patients who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.