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Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of HCC: A Multicenter Randomized Controlled Trial (TRACE Trial)


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

Transarterial RAdioembolization Versus ChemoEmbolization for the Treatment of HCC: A Multicenter Randomized Controlled Trial (TRACE Trial)


Inclusion Criteria:



- Written informed consent.

- The diagnosis HCC is confirmed by typical appearance on imaging or cytohistological
evaluation (liver biopsy).

- Accurate staging:

MRI of the liver CT-scan of the abdomen and thorax bone scintigraphy, only in case of
clinical symptoms suggestive of skeletal metastases.

Exclusion Criteria:

- Hypersensitivity to doxorubicin

- Pregnancy or breastfeeding

- Age under 18 years

- Child-Pugh score >B7

- ECOG performance status (PST) > 1

- Bilirubin > 2.6 mg/dl

- AST/ALT >5x upper limit of normal (ULN)

- >50% of liver involvement

- Main portal vein (right, left or common trunk) thrombosis

- Extra-hepatic disease

- Previous treatment of study target lesions

- 99mTc-labelled macroaggregated albumin (99mTc-MAA) scintigraphy shows lack of MAA
uptake in tumor (photopenic lesion)

- Activity > 610 MBq and activity reduction would imply a liver target dose > 80 Gy

- patients who are declared incompetent or suffering from physic disorders that make a
comprehensive judgement impossible, such as psychosis.

- Unmanageable intolerance for contrast medium

- Life expectancy < 3 months or otherwise impossible follow-up

- Inadequate bone marrow, liver and/or renal function

- other contraindications to hepatic embolization procedures.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to Progression (TTP).

Outcome Description:

Tumor progression is defined according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) response evaluation criteria. The mRECIST evaluation criteria define progressive disease by the implication of target lesions response, non-target lesions response and the occurrence of new lesions.

Outcome Time Frame:

Patients will be followed over a 2 years period.

Safety Issue:

No

Authority:

Belgium: Ethics Committee

Study ID:

2011/050

NCT ID:

NCT01381211

Start Date:

September 2011

Completion Date:

December 2016

Related Keywords:

  • Hepatocellular Carcinoma
  • Intermediate stage hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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