TACE With or Without Radiation Therapy in Treating Patients With Stage A-C Liver Cancer

NCT02070419 | Withdrawn Phase 2 DMC

• 4 other identifiers: CASE2212NCI-2014-00246CASE 2212P30CA043703
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized phase II trial studies how well transarterial chemoembolization (TACE) works compared with TACE plus radiation therapy in treating patients with end stage liver disease, liver tumors, or potential liver transplant candidates. TACE involves reaching up to the blood vessel that feeds the tumor through a catheter placed into the groin vessel. Once the physician has defined the vessel going to the tumor, chemotherapy is infused to the tumor and the vessel is blocked, maintaining the chemotherapy for longer time inside the tumor and stopping the blood flow that feeds the tumor. Stereotactic body radiation therapy (SBRT) is a type of radiation therapy that delivers radiation to the tumor cells but does not harm normal liver cells. It is not yet known whether TACE is more effective with or without SBRT in treating liver tumors.

Conditions

Adult Primary Hepatocellular Carcinoma; Recurrent Adult Primary Liver Cancer; Stage I Adult Primary Liver Cancer; Stage II Adult Primary Liver Cancer; Stage IIIA Adult Primary Liver Cancer

Outcome Measures

Primary Outcomes (3)

• Percentage change in gross tumor volume (GTV)

  Percentage of tumor response as defined as change in longest diameter of tumor compared to original tumor length

  Baseline to 3 months

• Difference in mean gross tumor volume (GTV), assessed using the RECIST method

  Difference in mean GTV from T0M and T3M calculated by a student t-test

  Baseline to 3 months

• Difference in tumor grade

  Difference in the grade of tumor (as defined by the RECIST criteria) at T0 and T3 calculated using Chi-square tests.

  Baseline to 3 months

Secondary Outcomes (5)

• Rate of downstaging

  Up to 6 months

• Grade 3 or 4 adverse events associated with liver tumors

  Up to 1 year

• Rate of local progression, based on RECIST criteria

  Up to 6 months

• Liver transplant achievement

  Up to 6 months

• Survival rate

  1 year

Study Arms (2)

Arm I (TACE)

ACTIVE COMPARATOR

Patients undergo (transarterial chemoembolization) TACE according to institutional standard with doxorubicin-eluting beads.

Procedure: transarterial chemoembolization

Arm II (TACE+SBRT)

EXPERIMENTAL

Patients undergo transarterial chemoembolization (TACE) as in Arm I and 3 or 5 fractions of stereotactic radiosurgery (SBRT) given at least 48 hours apart over 14 days.

Procedure: transarterial chemoembolization; Radiation: stereotactic radiosurgery

Interventions

transarterial chemoembolization PROCEDURE

Undergo TACE with doxorubicin-eluting beads

Also known as: TACE

Arm I (TACE); Arm II (TACE+SBRT)

stereotactic radiosurgery RADIATION

Undergo SBRT

Arm II (TACE+SBRT)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HCC is staged as Barcelona A to C
• Treatment with SBRT can occur within 6 weeks of registration
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Patient has
• Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or
• Histological confirmation of HCC as determined by the Liver Tumor Board
• Hemoglobin greater than 10.0 g/dL
• Total bilirubin less than 3.0 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]) =\< 3 X institutional upper limit of normal
• Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 X institutional upper limit of normal
• Total aggregate of maximal dimension of liver tumors is =\< 8 cm
• Cirrhotic patients Child Pugh class A or B (score =\< 7)
• Patient must be determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (magnetic resonance imaging \[MRI\]/computed tomography \[CT\] scan) three months post final treatment
• Absolute neutrophil count \>= 1,500/μl
• Platelet count \>= 50,000 μl (after transfusion if required)

You may not qualify if:

• Patient with previous history of abdominal radiation
• Cirrhotic patients Child Pugh class B with score \>= 8
• Prior invasive malignancy other than primary liver malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years
• Evidence of metastatic disease prior to registration
• Evidence of main portal vein thrombosis
• History of known cardiac ischemia or stroke within last 6 months
• Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppression that would constitute a contraindication to liver transplantation

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

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

• Juan Sanabria

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2014
• First Posted: February 25, 2014
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: December 2, 2014

Record last verified: 2014-12