Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Live… (NCT02626312) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function
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 range18 Years
SexALL
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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…
What they're measuring
1
Maximum dose constraint
Timeframe: 4-8 weeks after completion of radiation therapy