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

NCT02626312 | Active Not Recruiting Phase 1 FDA Drug

• 3 other identifiers: 2015-0052P30CA016672NCI-2016-00006
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholangiocarcinoma; Cirrhosis; Hepatocellular Carcinoma; Metastatic Malignant Neoplasm in the Liver

Outcome Measures

Primary Outcomes (1)

• Maximum dose constraint

  Defined as the highest level dose constraint at which no more than 1 of 6 evaluable patients has had a dose limiting toxicity. Toxicities will be summarized with frequency by type, severity and their relationship to the treatment.

  4-8 weeks after completion of radiation therapy

Secondary Outcomes (4)

• Local disease control rate

  Up to 2 years

• Tumor response

  Up to 2 years

• Patterns of failure

  Up to 2 years

• Overall survival

  Up to 2 years

Other Outcomes (1)

• Tumor biomarker expression in serum

  Baseline

Study Arms (1)

Treatment (radiation therapy)

EXPERIMENTAL

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.

Other: Laboratory Biomarker Analysis; Procedure: Magnetic Resonance Imaging; Radiation: Radiation Therapy; Other: Survey Administration

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (radiation therapy)

Magnetic Resonance Imaging PROCEDURE

Correlative studies

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Treatment (radiation therapy)

Radiation Therapy RADIATION

Undergo radiation therapy

Also known as: Cancer Radiotherapy, Irradiate, Irradiated, irradiation, Radiation, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation

Treatment (radiation therapy)

Survey Administration OTHER

Ancillary studies

Treatment (radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (2)

• Chang E, Holliday EB, Szklaruk J, Erwin WD, Ludmir EB, Noticewala SS, Das P, Koong AC, Minsky BD, Smith GL, Sawakuchi GO, Martin-Paulpeter RM, Niedzielski JS, Perles LA, Beddar S, Valino VS, Nguyen JL, Raghav KPS, Javle M, Kaseb AO, Dasari AN, Overman MJ, Parseghian CM, Odisio BC, Mahvash A, Kuban JD, Shen SE, Wang XS, Gupta AC, Al Taie MM, Brock KK, Tzeng CD, Vauthey JN, Wong FCL, Koay EJ. Single-photon emission computed tomography functional liver imaging to facilitate reirradiation for liver malignancies: A phase I trial. JHEP Rep. 2026 Apr;8(4):101743. doi: 10.1016/j.jhepr.2026.101743. Epub 2026 Jan 22.

  PMID: 41825097 DERIVED

• Chang E, Wong FCL, Chasen BA, Erwin WD, Das P, Holliday EB, Koong AC, Ludmir EB, Minsky BD, Noticewala SS, Smith GL, Taniguchi CM, Rodriguez MJ, Beddar S, Martin-Paulpeter RM, Niedzielski JS, Sawakuchi GO, Schueler E, Perles LA, Xiao L, Szklaruk J, Park PC, Dasari AN, Kaseb AO, Kee BK, Lee SS, Overman MJ, Willis JA, Wolff RA, Tzeng CD, Vauthey JN, Koay EJ. Phase I trial of single-photon emission computed tomography-guided liver-directed radiotherapy for patients with low functional liver volume. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae037. doi: 10.1093/jncics/pkae037.

  PMID: 38730548 DERIVED

MeSH Terms

Conditions

Cholangiocarcinoma; Fibrosis; Carcinoma, Hepatocellular

Interventions

Magnetic Resonance Spectroscopy; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Therapeutics; Physical Phenomena

Study Officials

• Eugene J Koay

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 10, 2015
• Study Start: February 15, 2016
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): April 28, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)