Trial record 10 of 1404 for:    "Liver Neoplasms"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT02070419
First received: February 21, 2014
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Adult Primary Hepatocellular Carcinoma
Recurrent Adult Primary Liver Cancer
Stage A Adult Primary Liver Cancer (BCLC)
Stage B Adult Primary Liver Cancer (BCLC)
Stage C Adult Primary Liver Cancer (BCLC)
Procedure: transarterial chemoembolization
Radiation: stereotactic radiosurgery
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Trans-Arterial Chemo-Embolization (TACE) vs TACE Plus Stereotactic Body Radio Therapy (SBRT) in the Treatment of Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:
  • Percentage change in gross tumor volume (GTV) [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    Percentage of tumor response as defined as change in longest diameter of tumor compared to original tumor length

  • Difference in mean gross tumor volume (GTV), assessed using the RECIST method [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    Difference in mean GTV from T0M and T3M calculated by a student t-test

  • Difference in tumor grade [ Time Frame: Baseline to 3 months ] [ Designated as safety issue: No ]
    Difference in the grade of tumor (as defined by the RECIST criteria) at T0 and T3 calculated using Chi-square tests.


Secondary Outcome Measures:
  • Rate of downstaging [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Rate of downstaging of stage A to C Hepatocellular Carcinoma using TACE plus SBRT when compared to TACE at 3 and 6 months.

  • Grade 3 or 4 adverse events associated with liver tumors [ Time Frame: Up to 1 year ] [ Designated as safety issue: Yes ]
    Number of grade 3 or 4 adverse events associated with SBRT for liver tumors, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events

  • Rate of local progression, based on RECIST criteria [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Rate of local disease progression when progression is defined as an estimated increase of > 20% in the sum of the longest diameter of target lesions, taking as reference the smallest sum of the longest diameter recorded since the treatment started or the appearance of one or more new lesions.

  • Liver transplant achievement [ Time Frame: Up to 6 months ] [ Designated as safety issue: No ]
    Number of patients who achieve liver transplantation

  • Survival rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The number of days from the first day of treatment on study until death of any cause


Estimated Enrollment: 44
Study Start Date: February 2014
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (TACE)
Patients undergo (transarterial chemoembolization) TACE according to institutional standard with doxorubicin-eluting beads.
Procedure: transarterial chemoembolization
Undergo TACE with doxorubicin-eluting beads
Other Name: TACE
Experimental: Arm II (TACE+SBRT)
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
Undergo TACE with doxorubicin-eluting beads
Other Name: TACE
Radiation: stereotactic radiosurgery
Undergo SBRT

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine in patients with stage A to C hepatocellular carcinoma, if stereotactic body radiotherapy after TACE enhanced the response rate of hepatocellular carcinoma (HCC) when compared to TACE alone at 3 months.

SECONDARY OBJECTIVES:

I. To determine in patients with stage A to C hepatocellular carcinoma, if TACE plus SBRT can achieve a downstaging rate of >= 30% at 3 and 6 months.

II. To determine the rate of grade 3 or 4 adverse events associated with SBRT for liver tumors.

III. To determine the rate of local progression after SBRT. (Based on Response Evaluation Criteria in Solid Tumors [RECIST] criteria) IV. Number of patients who achieve liver transplantation. V. Overall survival.

OUTLINE: Patients are randomized to 1 of 2 treatment arms after the first loco-regional therapy with TACE.

ARM I: Patients undergo TACE according to institutional standard with doxorubicin-eluting beads.

ARM II: Patients undergo TACE as in Arm I and 3 or 5 fractions of SBRT given at least 48 hours apart over 14 days.

After completion of study treatment, patients are followed up at 1, 3, and 6 months and then periodically thereafter.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
  • Life expectancy > 12 weeks
  • Subjects must have the ability to understand and be willing to provide written informed consent
  • Women of child-bearing potential must have a negative pregnancy test within 4 weeks to the start of the SBRT treatment
  • Women must not be pregnant or nursing
  • Sexually active women must agree to use accepted forms of birth control; acceptable options for birth control will be documented in the consent and discussed with the subject prior to enrollment

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02070419

Locations
United States, Ohio
Case Comprehensive Cancer Center Not yet recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Juan R. Sanabria    440-232-0690    Juan.sanabria@uhhospitals.org   
Principal Investigator: Juan R. Sanabria         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
Principal Investigator: Juan Sanabria Case Comprehensive Cancer Center
  More Information

No publications provided

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02070419     History of Changes
Other Study ID Numbers: CASE2212, NCI-2014-00246, CASE2212, CASE 2212, P30CA043703
Study First Received: February 21, 2014
Last Updated: February 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Liver Neoplasms
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on August 21, 2014