Last updated on May 2018

Phase I Trial of Radiation Therapy in Patients With Liver Cancers and Impaired Liver Function

Brief description of study

The goal of this clinical research study is to find out if the new method of giving radiation to the liver can be given safely to patients who already have liver problems.

Detailed Study Description

Study Groups and Radiation Administration:

If you are found to be eligible to take part in this study, you will be assigned to a dose level of radiation based on when you join this study and on your screening test results. The dose level of radiation measures how much radiation the healthy parts of the liver and other organs can safely receive during radiation therapy. Two (2) dose levels of radiation will be tested. Three (3) to 6 participants will be enrolled at each dose level. The first group of participants will receive a standard dose level. The second group will receive either a higher or lower dose level than the group before it, depending on what side effects are seen. This will continue until the highest tolerable dose level is found. Up to 10 participants will receive radiation at the highest dose level that was found in the first part of the study.

Radiation Therapy:

You will receive radiation therapy up to 5 days a week for a total of either 15 or 25 doses, based on what the doctor thinks is in your best interest. Each dose of radiation you receive should take about 5-10 minutes, but the appointment for each dose of radiation will last about 1 hour. The study doctor can explain in more detail how the radiation will be given.

You may receive chemotherapy as part of your standard care while you are on study if your regular doctor thinks it is in your best interest.

Study Visits:

One (1) time each week while you are receiving radiation:

  • You will have a physical exam.
  • Blood (up to 2 teaspoons) will be drawn for routine tests.
  • You will be asked to complete the symptom questionnaire in person, over the internet, or by telephone.

Length of Study Participation:

You will receive radiation therapy for 15 or 25 treatments. You will no longer be able to receive radiation treatment if the disease gets worse, if intolerable side effects occur, if the study doctor thinks it is in your best interest, or if you are unable to follow study directions.

Your participation on the study will be over after the follow-up visits.

Follow-Up Visits:

About 4-8 weeks after you complete radiation therapy, you will return to the clinic for follow-up visits. You will have follow-up visits every 3 months during the first year (+/- 1 month) after radiation therapy, and every 4 months (+/- 1 month) in the second year after radiation therapy. If the disease gets worse or you start another therapy you will have follow-up visits every 6 months (+/1 month) for up to 2 years. At each visit you will have the following tests and procedures:

  • You will have a physical exam.
  • Blood (up to 2 teaspoons) will be drawn for routine tests.
  • You will have an MRI, CT scan, and/or positron emission tomography (PET)/CT to check the status of the disease.
  • Each week, you will fill out the symptoms questionnaire during the follow-up period in person, over the internet, or by telephone. This questionnaire should take about 10 minutes.

This is an investigational study. Radiation therapy is delivered using FDA-approved and commercially available methods. Combining advanced radiation therapy techniques with functional imaging for patients with liver cancer and with decreased liver function is considered investigational.

Up to 88 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02626312

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Recruitment Status: Open

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