Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2017-10-26
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TACE
Transarterial chemoembolization with drug eluted beads or doxorubicin/lipiodol
DEB
Infusion of DEB or doxorubin/lipiodol through catheter in the hepatic artery
SBRT
Stereotactic radiation therapy with risk adapted dose prescription
SBRT
High precision radiation therapy to the liver tumor(s)
Interventions
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DEB
Infusion of DEB or doxorubin/lipiodol through catheter in the hepatic artery
SBRT
High precision radiation therapy to the liver tumor(s)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Number of lesions: not more than 3 lesions
* Lesion size: up to 10 cm for a single lesion (and up to 10 cm cumulative diameter, if there is more than 1 lesion)
* Child-Pugh A or B (\<7) on examination within 6 weeks prior to study entry
* BCLC Stage A/B
* Must be fit (eligible) for SBRT and TACE
* Unsuitable/unwilling for resection or transplant or radiofrequency ablation (RFA) or if these options are not available
* Distance between GTV (lesion) and luminal structures (including esophagus, stomach, duodenum, small or large bowel) is \>10 mm
* All blood work obtained within 2 weeks prior to study entry with adequate organ function defined as follows:
* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
* Platelets ≥50,000 cells/mm3
* Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.)
* Total bilirubin \< 2 mg/dL
* Prothrombin time/INR \< 1.4 (unless on Coumadin/Warfarin)
* Albumin ≥ 28 g/L
* AST (and ALT) \< 5 times ULN
* Serum creatinine ≤ ULN or creatinine clearance ≥ 60 mL/min
* Left-ventricular ejection fraction \>50% (cardiac ejection fraction should be measured in case of history of cardio-vascular disease.
* May have had previous surgery, ethanol injection and RFA to the liver
Exclusion Criteria
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 2 years (Note that carcinoma in situ of the breast, oral cavity, or cervix are all permissible). No active cancer therapy.
* Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE)
* Non-enhancing HCC on CT or CT-angio or
* Portal vein thrombosis/macroscopic venous invasion
* Arterio-portal and arterio-venous fistulas observed on pre-study imaging (if it is found during the TACE, the fistula may be embolized before injection of the drug).
* Evidence of metastatic disease including nodal or distant metastases.
* Previous TACE or radiation to the liver (including SIRT)
* Life-threatening condition (including untreated HIV and active hepatitis B/C)
* Detectable HBeAg and HBV viral load \> 20,000 IU/mL or
* HBeAg-negative chronic hepatitis B and HBV viral load \>2,000 IU/mL
* If HBV-DNA copy is higher than 500 copies/ml, anti-viral therapy, such as Entecavir followed by observation for 2 weeks.
* If anti-HCV antibody is positive (may be false positive) and increased HCV viral load indicating active disease. Active HCV should be treated sufficiently before inclusion in the study. Below 2 million copies per milliliter (mL) is related to chronic hepatitis C that does not need antiviral therapy.
* Patients with active hepatitis B or C should be on treatment for at least 4 weeks before inclusion in the trial
* On sorafenib or other antineoplastic drug therapy within 7 days before inclusion (not accepted until time of progression).
* Pregnancy or women of childbearing potential require a negative pregnancy test within 28 days
18 Years
75 Years
ALL
No
Sponsors
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International Atomic Energy Agency
OTHER_GOV
University of Aarhus
OTHER
Responsible Party
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Locations
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Medanta
Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Tejinder Kataria, Dr
Role: primary
Other Identifiers
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UAarhus HCC
Identifier Type: -
Identifier Source: org_study_id