Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function

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Brief Title

Radiation Therapy in Treating Patients With Hepatocellular Carcinoma, Cholangiocarcinoma, or Liver Metastasis Who Have Impaired Liver Function

Official Title

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

Brief 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.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To evaluate the safety of high dose radiotherapy in patients who have liver tumors
      (hepatocellular carcinoma [HCC]/cholangiocarcinoma/liver metastases from any primary) and who
      have impaired liver function or low functional liver volume or who have received prior liver
      radiation.

      SECONDARY OBJECTIVES:

      I. To evaluate 2 year local control with radiotherapy in these patients. II. To evaluate
      tumor response, patterns of failure, and survival in these patients.

      III. To evaluate imaging- and serum-based biomarkers in these patients, as correlates of
      hepatic toxicity and tumor response.

      OUTLINE: This is a dose-escalation study.

      Patients undergo radiation therapy 5 days a week for a total of 15 or 25 fractions in the
      absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up at 4-8 weeks and then every 3-4
      months for 2 years. Patients who progress during the two year follow-up period are followed
      up every 6 months.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Maximum dose constraint

Secondary Outcome

 Local disease control rate

Condition

Cholangiocarcinoma

Intervention

Laboratory Biomarker Analysis

Study Arms / Comparison Groups

 Treatment (radiation therapy)
Description:  Patients undergo radiation therapy 5 days a week for a total of 15 or 25 fractions in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

88

Start Date

February 15, 2016


Primary Completion Date

February 28, 2022

Eligibility Criteria

        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 radioembolization (Y90 RE); the interval between
                  prior EBRT and re-irradiation on protocol should be equal to or greater than 12
                  months; the interval between prior Y90 RE and re-irradiation on protocol should
                  be equal to or greater than 6 months;

                    -  Cirrhosis group:

                         -  Child-Pugh class A5;

                         -  Borderline Child-Pugh class A6;

                         -  The patients in this 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

               -  Low functional liver volume without underlying 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 (CT or MRI) or SPECT/CT with Tc-99m sulfur
                       colloid; there is no upper limit on the functional liver volume for these
                       patients

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

          -  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

          -  Prior history of surgical resection, chemotherapy, transarterial chemoembolization
             (TACE), and/or radiofrequency ablation are allowed

          -  Expected survival must be greater than 3 months

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

          -  Signed study-specific consent form

        Exclusion Criteria:

          -  Prior liver-directed radiation therapy in cohort 1 (advanced cirrhosis group) or
             cohort 2 (low functional volume group)

          -  Prior yttrium-90 therapy for patients in cohorts 1 or 2

          -  Patients with a Child-Pugh score less than 6 or greater than 9 for radiation naive
             patients with cirrhosis (cohort 1)

          -  Child-Pugh score of greater than 6 for patients with cirrhosis who previously received
             liver directed radiation (EBRT or Y90 RE) (cohort 3)

          -  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

          -  Current evidence of fever or untreated infection

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

          -  Poorly controlled inflammatory bowel disease

          -  Women with a positive pregnancy test

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

          -  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 prostate-specific antigen (PSA) can be enrolled
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Eugene J Koay, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02626312

Organization ID

2015-0052

Secondary IDs

NCI-2016-00006

Responsible Party

Sponsor

Study Sponsor

M.D. Anderson Cancer Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Eugene J Koay, Principal Investigator, M.D. Anderson Cancer Center


Verification Date

July 2019