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

• Status: Recruiting
• Trial end date: 0000-00-00
• Target enrollment: 88
• Participant gender: Both

Summary

At this time, patients who have a cancer in the liver and who already have liver damage from cirrhosis, chemotherapy, or surgery may not be able to receive radiation therapy to the liver. Radiation to the liver in these patients may cause excessive liver damage. New methods of giving radiation to the liver may help these patients receive radiation therapy to help control cancer.

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: Liver Extracts
• Last Updated: 2016-12-15

Criteria

Inclusion Criteria:

1. Diagnosis of hepatocellular carcinoma, cholangiocarcinoma, or liver metastasis from any histology

2. Patients may have single or multinodular tumors

3. There is no specific tumor size cut-off for this protocol. However, the radiation treatment plan must meet the protocol's dose constraints.

4. Age 18 or older

5. Compromised liver function as defined by any of the following: a. 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 (CT or MRI) or SPECT/CT with Tc-99m sulfur colloid. There is no upper limit on the functional liver volume for these patients; b. 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

6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

7. Women of childbearing potential (those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to practice adequate contraception and to refrain from breast feeding.

8. Prior history of surgical resection, chemotherapy, TACE, and/or radiofrequency ablation are allowed.

9. Expected survival must be greater than 3 months

10. Patients may receive concurrent capecitabine or sorafenib at the discretion of the treating physicians

11. Signed study-specific consent form

Exclusion Criteria:

1. Prior liver-directed radiation therapy

2. Prior Yttrium-90 therapy

3. Patients with a Child-Pugh score less than 6 or greater than 9

4. Unstable angina, and/or symptomatic congestive heart failure requiring hospitalization within the last 6 months. Transmural myocardial infarction within the last 6 months prior to study entry.

5. Current evidence of fever or untreated infection

6. Active hepatitis, including but not limited to viral and drug-induced

7. Poorly controlled inflammatory bowel disease

8. Women with a positive pregnancy test

9. Inability to comply with study and/or follow-up procedures

10. Patients with an active second malignancy or prior invasive malignancy unless disease free for a minimum of 3 years. Non-melanoma skin cancer and previous early prostate cancer that had a non-rising PSA can be enrolled.