Trial | NCT01327521  Report issue

Title

Transarterial Chemoembolization vs CyberKnife for Recurrent Hepatocellular Carcinoma
International Randomized Study of Transarterial Chemoembolization Versus CyberKnife for Recurrent Hepatocellular Carcinoma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
Primary Objective:

To compare the efficacy of TACE vs. CyberKnife SBRT in the treatment of locally recurrent HCC after initial TACE.

Secondary Objectives:

To determine the progression-free survival of TACE vs. CyberKnife SBRT
To determine the overall survival of TACE vs. CyberKnife SBRT for locally recurrent HCC
To determine the toxicities associated with TACE or CyberKnife SBRT for the treatment of recurrent HCC.
Study Started
Feb 28
2011
Primary Completion
Feb 28
2014
Anticipated
Last Update
Jun 11
2012
Estimate

Device CyberKnife

Standard of Care

  • Other names: CK

Procedure TACE

Standard of Care

  • Other names: Transcatheter arterial chemoembolization

Drug CT Contrast

Standard of Care

  • Other names: contrast dye

Drug doxorubicin

Standard of Care

  • Other names: Adriamycin, hydroxydaunorubicin

Drug Epirubicin

Standard of Care

  • Other names: Ellence, Pharmorubicin, Epirubicin Ebewe

Drug 5-fluorouracil

Standard of Care

  • Other names: Efudex, Fluoroplex, 5-FU, f5U, Adrucil, Carac, Efudix

Drug Mitomycin C

Standard of Care

  • Other names: Mutamycin, MTC

Drug Gemcitabine

Standard of Care

  • Other names: Gemzar

Drug Cisplatin

Standard of Care

  • Other names: cisplatinum, cis-diamminedichloroplatinum(II), CDDP, Platinol, Platinol-AQ

Device SMANCS

Standard of Care

  • Other names: styrene maleic acid neocarzinostatin, poppyseed oil

Criteria 

Inclusion Criteria:

Confirmed hepatocellular carcinoma by one of the following:

Histopathology
One radiographic technique that confirms a lesion >=2 cm with arterial enhancement with washout on delayed phase
Hepatic lesion in patients for whom surgical resection is not possible or would not result in an opportunity for cure
Radiographic evidence of persistent, progressive or recurrent disease in an area previously treated with TACE. This evaluation should be determined after 6 weeks of initial TACE

Multi-specialty evaluation whereby the recurrent liver lesion was deemed by both the attending radiation oncologist and interventional radiologist amenable to treatment by the respective modality

Eligible patients must undergo an IV contrast CT scan of the liver within 6 weeks of enrollment onto the study; a contrast enhanced liver MRI may be substituted for the IV contrast CT of the liver.
A recent serum AFP must also be obtained within 4 weeks of enrollment.
Unifocal liver tumors not to exceed 7.5 cm in greatest axial dimension. Multifocal lesions will be restricted to lesions that can be treated within a single target volume within the same liver segment and to an aggregate of 7.5cm as long as the dose constraints to normal tissue can be met
Eastern Clinical Oncology Group performance status 0, 1 or 2
Patients with liver disease classified as Child Pugh class A/B; if Child's class B, score must be 8 or less
Albumin >= 2.5 g/dL
Total bilirubin <= 3 mg/dL
INR <= 1.5
Creatinine <= 2.0 mg/dL
Age >= 18 years old
Life expectancy>= 6 months
Ability of the research subject or authorized legal representative to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

Prior radiation for the recurrent liver tumors
Prior radiotherapy to the upper abdomen
Prior RFA to index lesion
Liver transplant
Tumors >= 7.5 cm in greatest axial dimension
Portal vein thrombus
Large varices within 2 cm of index lesion (seen on cross section imaging)
Contraindication to receiving radiotherapy
Active gastrointestinal bleed within 2 weeks of study enrollment
Ascites refractory to medical therapy
Women who are pregnant
Administration of any systemic chemotherapy within the last 1 month
Presence of multifocal lesions located in different lobes of the liver or extrahepatic metastases
Participation in another concurrent SYSTEMIC treatment protocol
Prior history of malignancy other than HCC
No Results Posted