Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Live… (NCT02626312) | Clinical Trial Compass
TerminatedPhase 1
Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function
Stopped: \< 75% participation
United States36 participantsStarted 2016-02-15
Plain-language summary
This phase I trial studies the side effects and the best dose of radiation therapy in treating patients with hepatocellular carcinoma, cholangiocarcinoma, or cancer that has spread from the original (primary) tumor to the liver who also have impaired liver function (liver damage caused by cirrhosis, chemotherapy, or surgery). Radiation therapy (RT) uses high energy x-rays to kill tumor cells and shrink tumors. New methods of giving RT to the liver may help control cancer.
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:
* Diagnosis of hepatocellular carcinoma, cholangiocarcinoma, or liver metastasis from any histology
* Patients may have single or multinodular tumors
* There is no specific tumor size cut-off for this protocol; however, the radiation treatment plan must meet the protocol's dose constraints
* Compromised liver function as defined by any of the following:
* Cohort 1: Advanced cirrhosis group
* Borderline Child-Pugh class A6
* Child-Pugh class B
* The patients in this advanced cirrhosis group must have at least 400 ml of functional liver, as estimated on either diagnostic imaging (computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) or single photon emission computed tomography (SPECT)/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients
* Cohort 2: Low functional liver volume without underlying chronic liver disease
* Previous irinotecan or oxaliplatin chemotherapy
* Previous liver resection(s)
* These patients must have at least 400 ml of functional liver, as estimated by either diagnostic imaging computed tomography or magnetic resonance imaging (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid; there is no upper limit on the functional liver volume for these patients;
* Cohort 3: History of prior liver-directed radiation therapy with either fractionated external beam radiation therapy (EBRT), stereotactic body radiation therapy (SBRT) or yttrium-90 ra…
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.
1This trial was terminated before completing — do you know why it was stopped, and does that affect whether its findings would be relevant to my situation?
2Since this was a Phase 1 trial focused on finding the maximum safe radiation dose rather than proving effectiveness, what does that mean for what we actually know about both the risks and the potential benefits for someone with my liver condition?
3My liver function is already impaired — how would participating in or being informed by a radiation trial like this one compare to standard treatment options that are already established for my diagnosis?
4This trial was specifically designed for patients with impaired liver function due to conditions like cirrhosis — given my current liver status, how would my doctor assess whether my liver could tolerate the radiation doses being studied here?
5Are there other active trials or newer radiation approaches that built on what this terminated study was trying to learn, and would any of those be worth exploring for my type of liver cancer?
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
Maximum dose constraint
Timeframe: 4-8 weeks after completion of radiation therapy