Trial record 1 of 1 for:    NCT01556490
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Efficacy Evaluation of TheraSphere in Patients With Inoperable Liver Cancer (STOP-HCC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by BTG International Inc.
Sponsor:
Collaborator:
Biocompatibles UK Ltd
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01556490
First received: March 13, 2012
Last updated: March 16, 2015
Last verified: April 2014
  Purpose

The safety and effectiveness of TheraSphere will be evaluated in patients with unresectable hepatocellular carcinoma in whom treatment with standard-of-care sorafenib is planned. All patients receive the standard-of-care sorafenib with or without the addition of TheraSphere.


Condition Intervention Phase
Unresectable Hepatocellular Carcinoma
Device: TheraSphere
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III Clinical Trial of Intra-arterial TheraSphere® in the Treatment of Patients With Unresectable Hepatocellular Carcinoma (HCC)

Resource links provided by NLM:


Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From time of randomization up to 45 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 390
Study Start Date: March 2012
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: July 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control group
Standard-of-care sorafenib, with no added therapy
Experimental: Treatment group
Standard-of-care sorafenib plus TheraSphere
Device: TheraSphere
Yttrium 90 microspheres

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent prior to any study-related evaluation
  • Male or female patients over 18 years of age
  • Unresectable HCC confirmed by histology or by non-invasive AASLD criteria
  • Measurable disease defined as at least one uni-dimensional measurable lesion by CT or MRI according to RECIST 1.1
  • Child Pugh score ≤ 7 points
  • ECOG Performance Status score of ≤ 1
  • Life expectancy of 12 weeks or more
  • Eligible to receive standard-of-care sorafenib
  • Platelet count of > 50 x 10⁹ or > 50% prothrombin activity
  • Hemoglobin ≥ 8.5 g/dL
  • Bilirubin ≤ 2.5 mg/dL
  • ALT and AST< 5 X upper limit of normal
  • Amylase and lipase ≤ 2X upper limit of normal
  • Serum creatinine ≤ 1.5 X upper limit of normal
  • INR < 2.0

Exclusion Criteria:

  • Main portal vein thrombosis
  • Eligible for curative treatment (ablation or transplantation)
  • History of previous or concurrent cancer other than HCC unless treated curatively 5 or more years prior to entry
  • Confirmed presence of extra-hepatic disease except lung nodules and mesenteric or portal lymph nodes ≤ 2.0 cm each
  • Risk of hepatic or renal failure
  • Tumor replacement > 70% of total liver volume based on visual estimation by investigator OR tumor replacement >50% of total liver volume in the presence of albumin <3 mg/dL
  • History of severe allergy or intolerance to contrast agents, narcotics sedatives or atropine that cannot be managed medically
  • Contraindications to angiography and selective visceral catheterization
  • Known contraindications to sorafenib including allergic reaction, pill-swallowing difficulty, evidence of severe or systemic diseases, uncontrolled hypertension or history of cardiac arrhythmias (requiring anti-arrhythmic therapy or pace maker), congestive heart failure . New York Heart Association class 2, myocardial infarct within 6 months, prolonged QT/QTc >450ms, or laboratory finding that in the view of the investigator makes it undesirable for the patient to participate in the trial, significant GI bleed within 30 days, metastatic brain disease, renal failure requiring dialysis
  • Taking any of the following: Rifampicin, St. John's Wort, phenytoin, carbamazepine, phenobarbital, dexamethasone
  • Taking any other systemic anticancer agent (docetaxel, doxorubicin, irinotecan)
  • Taking any substrate agents for CYP 2B6 (bupropion, cyclophosphamide, efavirenz, ifosfamide, methadone, paclitaxel, amodiaquine, repaglinide)
  • Taking any UGT 1A1 and UGT 1A9 substrates (e.g. irinotecan)
  • Taking P-Gp substrates (e.g. Digoxin)
  • Prior liver resection must have taken >2 months prior to randomization
  • Treatment with other locoregional therapies (other than study treatment) has not been planned for the duration of the clinical study period
  • Prior external beam radiation treatment to the liver or abdomen
  • Prior yttrium-90 microsphere treatment to the liver
  • Prior treatment with transarterial chemoembolization (TACE) or bland embolization >2 months prior to randomization and must have been applied to a treatment field and/or lobe not targeted for treatment under this protocol
  • Anti-cancer therapy or any treatment with an investigational agent within 30 days prior to randomization
  • Adverse effects due to prior therapy unresolved at randomization
  • Prior systemic treatment for the treatment of HCC, including sorafenib
  • Evidence of pulmonary insufficiency or clinically evident chronic obstructive pulmonary disease
  • Intervention for, or compromise of, the Ampulla of Vater
  • Clinically evident ascites (trace ascites on imaging is acceptable)
  • Pregnancy or breast feeding
  • Women of child-bearing potential must have a negative serum pregnancy test within 14 days prior to randomization
  • Disease or condition that would preclude safe use of TheraSphere, including concurrent dialysis treatment, or unresolved serious infections including patients who are known HIV positive
  • Participation in concurrent clinical trials evaluating treatment intervention(s)
  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: NCT01556490

Contacts
Contact: Ulrike Kritzler + 49 (6131) 2157818 Ulrike.Kritzler@TheoremClinical.com
Contact: Randy Brown 317-900-3335 randy.brown@theoremclinical.com

  Show 19 Study Locations
Sponsors and Collaborators
BTG International Inc.
Biocompatibles UK Ltd
Investigators
Principal Investigator: Riad Salem, MD, MBA Dept of Radiology Northwestern University
  More Information

Additional Information:
No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01556490     History of Changes
Other Study ID Numbers: TS-103
Study First Received: March 13, 2012
Last Updated: March 16, 2015
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 21, 2015