Chemoembolization With or Without Stereotactic Body Radiosurgery for Liver Cancer

NCT02304445 | Withdrawn

• 1 other identifier: MZ2014022
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open-label, active comparator-controlled trial of subjects with advanced (Barcelona stage B/C) hepatocellular carcinoma. Subjects will be receive one treatment with Trans-Arterial Chemo-Embolization (TACE) prior to randomization. Subsequently, subjects will be randomized to observation or, if indicated, up to an additional TACE treatments, or to Stereotactic Body Radiotherapy (SBRT). Tumor response following interventions will be evaluated at three months.

Conditions

Carcinoma, Hepatocellular

Keywords

Radiotherapy; Chemoembolization

Outcome Measures

Primary Outcomes (1)

• Tumor response rate

  Tumor Response Rate of stage B or C Hepatocellular Carcinoma using TACE vs. TACE plus SBRT at 3 months

  3 months

Secondary Outcomes (4)

• Tumor down staging

  3 and 6 months

• Frequency of adverse events

  6 months

• Incidence of local tumor progression

  6 months

• Number of patients eligibility for liver transplantation

  3 months

Other Outcomes (1)

• Overall survival

  3 years

Study Arms (2)

Transarterial Chemoembolization (TACE)

ACTIVE COMPARATOR

Subjects will randomized receive one TACE treatment then receive observation or up to 3 additional TACE treatments as clinically indicated.

Procedure: Transarterial Chemoembolization (TACE)

TACE+Stereotactic Body Radiotherapy

EXPERIMENTAL

Subjects will receive one TACE treatment then receive 1-5 Stereotactic Body Radiotherapy treatments.

Procedure: Transarterial Chemoembolization (TACE); Radiation: TACE+Stereotactic Body Radiotherapy

Interventions

Transarterial Chemoembolization (TACE) PROCEDURE

TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.

TACE+Stereotactic Body Radiotherapy; Transarterial Chemoembolization (TACE)

TACE+Stereotactic Body Radiotherapy RADIATION

This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.

TACE+Stereotactic Body Radiotherapy

Eligibility Criteria

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

You may qualify if:

• Hepatocellular carcinoma (Barcelona Stage B or C)
• Treatment with Stereotactic Body Radiosurgery can occur within 6 weeks of enrollment
• Age ≥ 18 years and ≤ 70 years
• Eastern Cooperative Oncology Group Performance status ≤ 2
• Patient has a) Radiographic enhancing liver lesions with early wash out on triple phase CT or MRI or b) histological confirmation of HCC as determined by the Liver Tumor Board
• Hemoglobin \> 10.0 g/dL
• Total bilirubin \> 3.0 mg/dL
• AST (SGOT) ≤ 3x institutional upper limit of normal
• ALT (SGPT) ≤ 3x institutional upper limit of normal
• Absolute neutrophil count ≥ 1,500/μl
• Platelet count ≥ 50,000/μl (may be post-transfusion if clinically indicated)
• Aggregate maximal dimension of liver tumors ≤ 8 cm
• Cirrhosis classified as Child Pugh Class A or B (score ≤ 7)
• Determined by the treating physician to be medically eligible for liver transplantation measured by imaging modality (MRI/CT scan) three months post final treatment
• Life expectancy ≥ 12 weeks

You may not qualify if:

• History of abdominal radiation
• Cirrhosis classified as 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 cardiac ischemia or stroke within 6 months prior to enrollment
• Any concurrent medical or psychosocial condition that prohibits a major surgical procedure or immunosuppressant that would constitute a contraindication to liver transplantation
• History of sorafenib therapy within 21 days prior to enrollment

Sponsors & Collaborators

• Juan Sanabria, MD: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Officials

• Juan Sanabria, MD

  Midwestern Reginal Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician Surgical Oncology

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 2, 2014
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: November 26, 2015

Record last verified: 2015-11