Stereotactic Body Radiation Therapy and Transarterial Chemoembolization in Treating Patients With Liver Cancer That Cannot Be Removed by Surgery

NCT02507765 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: OSU-15032NCI-2015-00894
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies stereotactic body radiation therapy (SBRT) and transarterial chemoembolization (TACE) in treating patients with liver cancer that cannot be removed by surgery. SBRT is a specialized radiation therapy that delivers a high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Chemoembolization kills tumor cells by carrying drugs directly into blood vessels near the tumors and then blocking the blood flow to allow a higher concentration of the drug to reach the tumor for a longer period of time. SBRT may make TACE more beneficial by increasing blood flow to the tumor, which may allow more of the TACE chemotherapy to enter the tumor. Giving SBRT with TACE may work better in treating patients with liver cancer that cannot be removed by surgery.

Conditions

Child-Pugh Class A; Child-Pugh Class B; Stage IIIA Hepatocellular Carcinoma; Stage IIIB Hepatocellular Carcinoma; Stage IIIC Hepatocellular Carcinoma; Stage IVA Hepatocellular Carcinoma; Stage IVB Hepatocellular Carcinoma

Keywords

SBRT

Outcome Measures

Primary Outcomes (1)

• Feasibility of SBRT in combination with TACE, measured by the number of patients able to tolerate all study procedures

  Determined on the intent-to-treat principle. Any treatment delivery difficulties that arise that could impede successful delivery of this therapy sequence will be evaluated. The capability of the Ohio State University (OSU) system and communication between departments will be analyzed and deemed effective if it facilitates the successful treatment completion of all patients.

  2 days

Secondary Outcomes (8)

• Change in diffusion

  Baseline to day 1 post-SBRT

• Change in hypoxia measurements

  Baseline to day 1 post-SBRT

• Change in perfusion

  Baseline to day 1 post-SBRT

• Incidence of toxicities

  Up to 30 days

• Local control

  Up to 12 months

Other Outcomes (5)

• Change in BOLD response to oxygen breathing based on T2 contrast induced by deoxyhemoglobin serving as an endogenous contrast agent

  Baseline to day 1 post-SBRT

• Change in Kel (washout phase constant) values calculated from the DCE curve

  Baseline to day 1 post-SBRT

• Change in mean apparent diffusion coefficient generated from diffusion weighted images by using the b values

  Baseline to day 1 post-SBRT

Study Arms (1)

Treatment (SBRT, TACE)

EXPERIMENTAL

Patients undergo SBRT on day 1 and TACE on day 2.

Other: Laboratory Biomarker Analysis; Radiation: Stereotactic Body Radiation Therapy; Procedure: Transarterial Chemoembolization

Interventions

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (SBRT, TACE)

Stereotactic Body Radiation Therapy RADIATION

Undergo SBRT

Also known as: SBRT

Treatment (SBRT, TACE)

Transarterial Chemoembolization PROCEDURE

Undergo TACE

Also known as: TACE

Treatment (SBRT, TACE)

Eligibility Criteria

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

You may qualify if:

• Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:
• Histologically confirmed
• Magnetic resonance imaging (MRI) or computerized tomography (CT) findings consistent with hepatocellular carcinoma
• Alpha fetoprotein (AFP) \> 400 ng/mL AND evidence of at least one solid liver lesion \> 2 cm regardless of specific imaging characteristics on CT or MRI
• Patients must be non-transplantable, unresectable, or medically inoperable and eligible for TACE as determined by a multi-disciplinary team
• Absolute neutrophil count \>= 1.5 × 10\^9/L
• Hemoglobin \>= 9 g/dl
• Platelets \>= 50,000/mm\^3
• Prothrombin time (PT)/international normalized ratio (INR) and activated partial thromboplastin time (PTTa) =\< 1.5
• Albumin \>= 2.5 g/dL
• Alkaline phosphatase \< 5 x upper limit of normal (ULN)
• Total bilirubin =\< 2.0 mg/dL
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \< 5 x ULN
• Creatinine =\< 1.5 mg/dL and calculated creatinine clearance \>= 60 mL/min or 24-hour urine creatinine clearance \>= 60 mL/min
• Must have Childs-Pugh A or B liver disease

You may not qualify if:

• Childs-Pugh C liver function
• Major liver vascular invasion
• Prior radiation to the liver or other upper abdominal regions
• Must not have any evidence of bleeding diathesis or active gastrointestinal bleeding
• Any concurrent malignancy other than non-melanoma skin cancer, non-invasive bladder cancer, or carcinoma in situ of the cervix; patients with a previous malignancy without evidence of disease for \>= 3 years will be allowed to enter the trial
• History of active connective tissue disease (scleroderma)
• Subjects who are breast-feeding, or have a positive pregnancy test will be excluded from the study; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
• Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds)
• Any serious and/or unstable pre-existing medical disorder (aside from malignancy exception above), psychiatric disorder, or other conditions that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator; this could include severe, active co-morbidities such as:
• Uncontrolled cardiac disease (hypertension, unstable angina, myocardial infarction within last 6 months, uncontrolled congestive heart failure, cardiomyopathy with decreased ejection fraction)
• Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days of registration
• Hepatic insufficiency resulting in jaundice and/or coagulation defects

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• Varian Medical Systems: collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• Sebastian NT, Miller ED, Yang X, Diaz DA, Tan Y, Dowell J, Spain J, Rikabi A, Elliott E, Knopp M, Williams TM. A Pilot Trial Evaluating Stereotactic Body Radiation Therapy to Induce Hyperemia in Combination With Transarterial Chemoembolization for Hepatocellular Carcinoma. Int J Radiat Oncol Biol Phys. 2020 Dec 1;108(5):1276-1283. doi: 10.1016/j.ijrobp.2020.07.033. Epub 2020 Jul 23.

  PMID: 32712254 RESULT

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Terence Williams, MD, PhD

  Ohio State University Comprehensive 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: July 23, 2015
• First Posted: July 24, 2015
• Study Start: July 1, 2015
• Primary Completion: January 18, 2019
• Study Completion: January 5, 2021
• Last Updated: October 13, 2021

Record last verified: 2021-10

Locations

US (1)